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E-cigarettes

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  2. E-cigarettes
  3. UK sexual practices
  4. Hospitalisation and venous thromboembolism in pregnancy
  5. Autism and selective serotonin reuptake inhibitors in pregnancy
  6. Multiple pregnancies in the USA
  7. Childhood obesity and pregnancy
  8. Postmenopausal hormones and cognitive function
  9. Cervical screening—USA 2014
  10. New reports and guidelines
  11. Innovations and patents
  12. Legal matters
  13. Clinical trials

Electronic or e-cigarettes are being promoted by the tobacco industry, which is experienced in habit-forming drug marketing. They suggest that e-cigarettes are safer than conventional cigarettes but conveniently fail to address the issue of nicotine addiction.

E-cigarettes are battery powered and contain nicotine in an aerosol form using propylene glycol or glycerine as the propellant, to which are added flavours such as mint, fruit or chocolate. Apart from the nicotine and its effects on physiological processes, some brands have been found to contain irritants, genotoxins and animal carcinogens (Cobb NK et al. Am J Public Health 2010;100:2340–2).

On the positive side, e-cigarettes may be at least as effective as nicotine patches in helping smokers to quit according to Bullen et al. (Lancet 2013;382:1629–37) but unsurprisingly most people are suspicious of these promotions.

UK sexual practices

  1. Top of page
  2. E-cigarettes
  3. UK sexual practices
  4. Hospitalisation and venous thromboembolism in pregnancy
  5. Autism and selective serotonin reuptake inhibitors in pregnancy
  6. Multiple pregnancies in the USA
  7. Childhood obesity and pregnancy
  8. Postmenopausal hormones and cognitive function
  9. Cervical screening—USA 2014
  10. New reports and guidelines
  11. Innovations and patents
  12. Legal matters
  13. Clinical trials

The National Survey of Sexual Attitudes and Lifestyles (Natsal) is a study of UK citizens that gathers data about their sexual practices and attitudes. It takes place every 10 years and the third survey's findings have now been published with over 15 000 adults interviewed (www.thelancet.com/themed/natsal).

Two decades ago UK couples had sex six times per month rather than the present five, which is not much of a change, but numbers of partners and attitudes have shifted considerably. Again comparing the findings reported in 1990 to that observed in 2010 the following differences were found:

  1. women's number of partners over a lifetime was four but is now eight
  2. for men, the corresponding figures rose from nine to 12
  3. the reporting of same-sex sexual relationships rose from 2% to 8% for women and from 4% to 5% for men
  4. attitudes to same-sex relationships have become much more tolerant (being considered ‘not wrong at all’); more women feel that these are acceptable (28% previously versus 66% now) and men's views have also changed (23% previously versus 50% now).

Torjesen reporting on these findings (BMJ 2013;347:f7087) says that the reduction in sexual frequency may be due to more sexual partners not living together and the observed change in sexual attitude change shows an increasing societal acceptance of sexual diversity.

Wisely, there is no speculation on the generalisability of these data to other countries (Figures 1, 2 and 3).

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Figure 1. Change in number of sexual partners of the opposite sex 1990–2010. Source: Mercer CH et al. Lancet 2013;382:1781–94.

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Figure 2. Change in number of same-sex partners 1990–2010. Source: Mercer CH et al. Lancet 2013;382:1781–94.

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Figure 3. Change in acceptance of same-sex relationships 1990–2010. Source: Mercer CH et al. Lancet 2013;382:1781–94.

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Hospitalisation and venous thromboembolism in pregnancy

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  2. E-cigarettes
  3. UK sexual practices
  4. Hospitalisation and venous thromboembolism in pregnancy
  5. Autism and selective serotonin reuptake inhibitors in pregnancy
  6. Multiple pregnancies in the USA
  7. Childhood obesity and pregnancy
  8. Postmenopausal hormones and cognitive function
  9. Cervical screening—USA 2014
  10. New reports and guidelines
  11. Innovations and patents
  12. Legal matters
  13. Clinical trials

Rates of venous thromboembolism (VTE) are markedly raised in pregnancy compared with outside pregnancy. However, this risk is further compounded if the woman is admitted to hospital. In fact, it rises 18-fold according to research from the UK (Sultan et al. BMJ 2013;347:f6099).

The study found that those women who were most at risk of VTE were those over the age of 35 years, in the third trimester and hospitalised for more than 3 days. Even after discharge from hospital, there was a six-fold risk for the following 28 days.

Although confident of the validity of their results, the researchers stop short of recommending thromboprophylaxis to all pregnant women admitted to hospital but clinicians should be aware of the dangers to high-risk women and administer the appropriate thromboprophylactic measures.

Autism and selective serotonin reuptake inhibitors in pregnancy

  1. Top of page
  2. E-cigarettes
  3. UK sexual practices
  4. Hospitalisation and venous thromboembolism in pregnancy
  5. Autism and selective serotonin reuptake inhibitors in pregnancy
  6. Multiple pregnancies in the USA
  7. Childhood obesity and pregnancy
  8. Postmenopausal hormones and cognitive function
  9. Cervical screening—USA 2014
  10. New reports and guidelines
  11. Innovations and patents
  12. Legal matters
  13. Clinical trials

The prevalence of autism has been increasing in recent years and the rise could be linked to intrauterine events. Serotonin is a neurotransmitter that has been detected as having increased blood levels in people with autism spectrum disorder (ASD) and it plays an important role in early brain development. Manipulation of serotonin levels by drugs in early pregnancy should therefore be explored for possible links with these disorders.

A Danish study looked at the incidence of ASD in the offspring of women taking selective serotonin reuptake inhibitors (SSRIs) before and during pregnancy and in children not exposed to these drugs (Hviid et al. N Engl J Med 2013;369:2406–15). They found an association on univariate analysis but when adjusting the data for co-founding factors this link was no longer statistically significant. Those women taking SSRIs had many other risk factors for ASD, such as higher than average levels of psychiatric illnesses, illicit drug use, smoking and lower standards of education, which all had to be factored into the observational research results.

Taking all these potential biases into account, the authors concluded that there is not a significant link between SSRI use prepregnancy or intrapregnancy and autism disorders.

Multiple pregnancies in the USA

  1. Top of page
  2. E-cigarettes
  3. UK sexual practices
  4. Hospitalisation and venous thromboembolism in pregnancy
  5. Autism and selective serotonin reuptake inhibitors in pregnancy
  6. Multiple pregnancies in the USA
  7. Childhood obesity and pregnancy
  8. Postmenopausal hormones and cognitive function
  9. Cervical screening—USA 2014
  10. New reports and guidelines
  11. Innovations and patents
  12. Legal matters
  13. Clinical trials

The USA does not have an enviable overall perinatal mortality rate for multiple pregnancies relative to other developed countries. One of the reasons may be the preterm delivery rate which, although showing a downward trend, remains twice that of many European countries. The use of assisted reproductive technology (ART) also plays a significant role in the number of multiple pregnancies, as well as increasing maternal age, which contributes to the high preterm delivery statistics (Kulkarni et al. N Engl J Med 2013;369:2218–25).

Just how important a contribution ART makes to multiple births is difficult to calculate because there are many instances of fertility treatments such as ovulation induction and ovarian stimulation being carried out under ‘unregulated’ circumstances. Until birth certification carries accurate information about conception details the precise figures pertaining to the causes of multiple births will remain unclear.

However, calculating the numbers of twins and triplets born since the introduction of ART four decades ago and comparing them with previous statistics gives an interesting picture. The data show that over these 40 years, overall one-third of twin pregnancies have been attributed to ART practices whereas three-quarters of triplets result from fertility treatments. These are broad statistics but more detailed figures show twin rates falling slightly (triplets even more so) as the numbers of embryos transferred in in vitro fertilisation programmes continue to drop from three or more embryos being the standard a decade ago to two or, preferably, one today. Elective fresh single transfers with back-up cryopreservation are becoming more popular with apparently little drop-off in live-born successes per cycle.

Childhood obesity and pregnancy

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  2. E-cigarettes
  3. UK sexual practices
  4. Hospitalisation and venous thromboembolism in pregnancy
  5. Autism and selective serotonin reuptake inhibitors in pregnancy
  6. Multiple pregnancies in the USA
  7. Childhood obesity and pregnancy
  8. Postmenopausal hormones and cognitive function
  9. Cervical screening—USA 2014
  10. New reports and guidelines
  11. Innovations and patents
  12. Legal matters
  13. Clinical trials

The problem of obesity in an individual may start with excessive weight gain as a child. This in turn may be determined by factors in pregnancy and the neonatal period when rapid weight accumulation is a potent predictor of obesity risk. Infants born early or who fail to grow during intrauterine life and exhibit ‘catch-up’ growth seem to be destined for later cardiovascular risk and metabolic disorders, which are also linked to obesity.

Other factors like maternal smoking, excessive weight gain in pregnancy, a short duration of breastfeeding and deprived sleep in infancy may all play a role in the risk of obesity in later life, mediated through leptin levels. One observational study has shown that if all these risk factors are present the prevalence of obesity in childhood is 28% whereas if none is present the prevalence is 4% (Gillman et al. Obesity 2008;16:1651–6). Children born by caesarean section can have different gut colonisation compared with those born vaginally, leading to modification of the intestinal microbiota and a propensity to becoming overweight.

Social, familial and economic environments may also play a role but peri-pregnancy events seem worth targeting in trying to turn the obesity pandemic around (Gillman and Ludwig N Engl J Med 2013;369:2173–5).

Postmenopausal hormones and cognitive function

  1. Top of page
  2. E-cigarettes
  3. UK sexual practices
  4. Hospitalisation and venous thromboembolism in pregnancy
  5. Autism and selective serotonin reuptake inhibitors in pregnancy
  6. Multiple pregnancies in the USA
  7. Childhood obesity and pregnancy
  8. Postmenopausal hormones and cognitive function
  9. Cervical screening—USA 2014
  10. New reports and guidelines
  11. Innovations and patents
  12. Legal matters
  13. Clinical trials

The Women's Health Initiative trial continues to provide data about the use of hormones postmenopausally. The latest information concerns the follow-up of younger women involved in the conjugated equine estrogen study, which concluded about 10 years ago.

Those taking estrogens (with or without progestogens) or placebo starting from the ages of 50–55 years and continuing for 7 years were tested for cognitive function 7 years after the trial was stopped (Espeland et al. JAMA Int Med 2013;173:1429–36). There were over 1000 participants but their cognitive function was no different if they took estrogens or placebo, which is reassuring because there have been some reports of detrimental effects of hormone therapy in older women.

Cervical screening—USA 2014

  1. Top of page
  2. E-cigarettes
  3. UK sexual practices
  4. Hospitalisation and venous thromboembolism in pregnancy
  5. Autism and selective serotonin reuptake inhibitors in pregnancy
  6. Multiple pregnancies in the USA
  7. Childhood obesity and pregnancy
  8. Postmenopausal hormones and cognitive function
  9. Cervical screening—USA 2014
  10. New reports and guidelines
  11. Innovations and patents
  12. Legal matters
  13. Clinical trials

Americans are among the world's most avid screeners of healthy people. They encourage screening for medical disorders such as hypertension, hyperlipidaemia and hyperglycaemia as well as for deleterious lifestyle habits and various cancers. The malignancies most commonly targeted are breast, prostate, cervix and colorectal.

In recent times there has been a realisation of the harms as well as the benefits of screening with a greater understanding of the natural history of the cancers being screened for—especially cervical cancer. These insights have led to a relaxing of the dogmatism associated with screening and longer intervals between screening recalls.

The latest recommendations from the USA about cervical screening are evidence based, using the pathophysiology of the role of human papillomavirus (HPV) in disease progression as a basis for their conclusions. They recognise the mechanism of HPV infection as being sexual and that peak rates coincide with a woman's coital debut and the decade thereafter. It is also accepted that HPV infections are almost always cleared by natural immunity within months and that the range of cytological abnormalities they cause will revert to normal in most cases.

The US recommendations therefore do not support any screening before the age of 21 years and suggest cytology testing being carried out at 3-yearly intervals till the age of 30 years. They do not recommend HPV testing (also known as molecular testing or simply co-testing) below the age of 30 years in normal circumstances.

Between the ages of 30 and 65 years the approach remains logical with cytological testing every 3 years or cytology plus co-testing every 5 years. HPV testing has a greater sensitivity in cancer detection and has a high negative predictive value so its incorporation into screening will reduce (if negative) the need for repeat cytology or colposcopy, which is costly. At present the cost of 50 million tests for screening plus follow-up of minor abnormalities comes to $6 billion annually (Schiffman and Solomon N Engl J Med 2013;369:2324–31).

They do not recommend any screening over the age of 65 years or for women who have had a total hysterectomy with no history of cancer. The guidelines do not take into account prevention with HPV vaccines because at present only about one-third of girls are receiving the vaccine in the USA. Perhaps if the proponents for screening showed the same enthusiasm for primary prevention there would be a reduction in costs and efficacy. No doubt an app will soon appear to individualise screening types and frequency, which will give maximum benefit for minimum costs!

New reports and guidelines

  1. Top of page
  2. E-cigarettes
  3. UK sexual practices
  4. Hospitalisation and venous thromboembolism in pregnancy
  5. Autism and selective serotonin reuptake inhibitors in pregnancy
  6. Multiple pregnancies in the USA
  7. Childhood obesity and pregnancy
  8. Postmenopausal hormones and cognitive function
  9. Cervical screening—USA 2014
  10. New reports and guidelines
  11. Innovations and patents
  12. Legal matters
  13. Clinical trials

WHO recommendations for the prevention and management of tobacco use and second-hand smoke exposure in pregnancy

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This World Health Organization (WHO) guideline aims to provide evidence-based recommendations for healthcare professionals, policymakers, programme managers and other service providers on the identification, management and prevention of tobacco use and second-hand smoke (SHS) exposure in pregnant women and to provide advice regarding the reduction of SHS exposure to others including those who live in the same household. The guideline discusses the prevalence and harms of tobacco use and SHS exposure during pregnancy and highlights existing national guidelines, global treaties and frameworks. Nine recommendations are presented for the prevention and management of tobacco use and SHS exposure in pregnancy including the assessment of tobacco use and SHS exposure in pregnancy, the psychosocial and pharmacological interventions for tobacco use cessation in pregnancy and protection from exposure to SHS during pregnancy in smoke-free homes and public places. Each recommendation is supported by a graded summary of the evidence that led to the generation of the recommendation. The recommendations are part of a larger programme of the Non-communicable Diseases and Mental Health cluster of the WHO, which aim to make recommendations regarding the management of substance abuse in pregnancy, covering tobacco, alcohol and other psychoactive substances. The guideline also includes information to aid dissemination, local adaptation and implementation and the evaluation of the impact of the guideline implementation.

Available online at www.who.int

Family planning worldwide 2013 data sheet

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This data sheet, published by the Population Reference Bureau, presents detailed regional and country-specific statistics related to society views and uptake of contraception. The data sheet highlights many trends including that modern contraceptive use varies considerably around the world, demand for family planning is high among young unmarried women, women in developing countries generally have more children than they would like, side effects and health concerns are common reasons for discontinuing injectable contraceptives, a woman's opportunity to make decisions generally relates to use of contraceptives and educated men are more open to women making decisions about family size. The data sheet is based on many data sources including Demographic and Health Surveys (ICF International and National Statistical Offices), Multiple Indicator Cluster Surveys (UNICEF), Pan-Arab Project for Family Health (PAPFAM) national surveys, World Contraceptive Use 2012 (United Nations Population Division), and Trends in Maternal Mortality: 1990–2010 (WHO, UNICEF, UNFPA and The World Bank).

Available online at www.prb.org

Responding to intimate partner violence and sexual violence against women: WHO clinical and policy guidelines

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These clinical and policy guidelines, produced by the Department of Reproductive Health and Research at the WHO, focus on the health sector response to intimate partner violence and sexual violence, and are aimed specifically at healthcare professionals. They provide evidence-based guidance to aid provision of appropriate clinical care and address the psychosocial needs of women who have experienced intimate partner violence and sexual violence. The publication of the guideline also aims to raise awareness of violence against women among policymakers and healthcare providers to help improve the response of health service providers to violence against women. The report states that between 13% and 61% of women aged 15–49 years report that an intimate partner has physically abused them at least once during their lifetime and that between 1% and 28% of women report that they were physically abused by an intimate partner during pregnancy. The recommendations outlined in the guideline cover six key areas: the provision of women-centred care; the identification of and care for survivors of intimate partner violence; the clinical care for survivors of sexual assault; the training of healthcare providers on intimate partner violence and sexual assault; healthcare policies and provision; issues relating to the mandatory reporting of intimate partner violence.

Available online at www.who.int

The influence of family dynamics on contraceptive use in Madagascar and the ensuing impact on family wellbeing

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This working paper, published by MEASURE Evaluation Population and Reproductive Health, explores the influence of family dynamics on use of contraceptives and the resultant impact on family wellbeing in Madagascar. The study, which aims to address two key questions (how do family dynamics influence contraceptive use and how are these influences and contraception decisions related to family wellbeing) was conducted in the Vatovavy Fitovinany region of Madagascar, which is reported as having one of the lowest contraceptive use rates nationally at 20.7% in 2008/09. A survey collecting data on demographics, access to social services, socio-economic status, family dynamics, and knowledge and practice of family planning was distributed to 1055 households in all six of the Vatovavy Fitovinany districts. Fifty-seven per cent of couples talk to, discuss with, and agree with each other on family planning decisions; 20.8% of couples talk to, discuss with, and agree with extended family on family planning decisions. About 96% of couples who have discussions do so with their spouse before others. There is evidence that while both spousal dynamics and extended family influence were associated with contraceptive use, spousal dynamics showed a stronger relationship. Analyses regarding wellbeing were inconclusive overall but suggest that spousal dynamics may also have a greater association with wellbeing than the influence from the extended family. The authors recommended the provision of continuing or increasing financial support and programme support to family planning services that promote inclusion of both men and women in family planning decision making and education as well as the promotion of family planning at community outreach sessions.

Available online at www.cpc.unc.edu

Innovations and patents

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  2. E-cigarettes
  3. UK sexual practices
  4. Hospitalisation and venous thromboembolism in pregnancy
  5. Autism and selective serotonin reuptake inhibitors in pregnancy
  6. Multiple pregnancies in the USA
  7. Childhood obesity and pregnancy
  8. Postmenopausal hormones and cognitive function
  9. Cervical screening—USA 2014
  10. New reports and guidelines
  11. Innovations and patents
  12. Legal matters
  13. Clinical trials

Patent applications

The following patents can be found online at http://worldwide.espacenet.com.

EP2684565 (A1) Use of ulipristal acetate for treating uterine fibroids. This patent application outlines a method for treating uterine fibroids involving the administration of an effective amount, in tablet form, of ulipristal acetate, to reduce or stop vaginal bleeding or reduce the size of uterine fibroids. The inventors state that a low dosage of 5–15 mg of ulipristal acetate (preferably 10 mg) given daily for about 2–4 months is the most effective dose.

Gainer E, Nieman L, Ulmann A, Blithe D. 15 January 2014.

EP2681566 (A2) Anti-müllerian hormone changes in pregnancy and prediction of adverse pregnancy outcomes and gender. This patent application proposes devices and methods for identifying women at risk of adverse pregnancy outcomes by determining the level of anti-müllerian hormone (AMH) in maternal blood. Levels of AMH from a pregnant woman will be assessed against a predetermined normal level from a control pregnant population. Abnormal levels of AMH, whether higher or lower than the predetermined normal level, are said to indicate an increased risk of adverse pregnancy outcomes. In addition, this patent also claims to provide a method of in utero determination of the gender of a fetus. Higher than normal AMH level in maternal blood is associated with a male fetus whereas lower than a normal level will be predictive of a female fetus.

This application claims priority to US Provisional Patent Application Serial No. 61/447,488 filed 28 February 2011. This provisional application is expressly incorporated by reference.

Stegmann BJ, Santillan DA, Santillan MK. 8 January 2014.

WO2014004922 (A1) Apparatus and methods for transurethral treatment of stress urinary incontinence.This patent application relates to systems and methods for transurethral treatment of stress urinary incontinence in women. Specifically this invention proposes the use of ultrasound energy from a delivery catheter or a multi-sectored tubular, planar, or curvilinear ultrasound applicator within the pelvic urethra, which targets surrounding tissues. It is postulated that the resultant moderate level of heat energy will induce tissue remodelling and increase the tissue density or stiffness of the endopelvic fascia to increase the resistance to urinary flow.

This application is a nonprovisional of US provisional patent application serial number 61/665,299 filed on 27 June 2012, incorporated herein by reference in its entirety.

Diederich CJ, Burdette EC, Wootton JH. 3 January 2014.

WO2014004677 (A1) Method of reducing the risk of pregnancy complications. This patent application discusses compositions and methods for use in pregnancy complication risk assessment and prevention, particularly in reducing the risk of complications such as pre-eclampsia and miscarriage. Specifically, this invention proposes the assessment of changes in maternal blood levels of peripheral regulatory T cells, which are stated as being associated with the incidence and/or risk of pregnancy complications.

This application claims priority to US Provisional Patent Application serial number 61/664,898, filed 27 June 2012; the entirety of which is hereby incorporated by reference.

Rudensky AY, Samstein R, Josefowicz S. 3 January 2014.

Legal matters

  1. Top of page
  2. E-cigarettes
  3. UK sexual practices
  4. Hospitalisation and venous thromboembolism in pregnancy
  5. Autism and selective serotonin reuptake inhibitors in pregnancy
  6. Multiple pregnancies in the USA
  7. Childhood obesity and pregnancy
  8. Postmenopausal hormones and cognitive function
  9. Cervical screening—USA 2014
  10. New reports and guidelines
  11. Innovations and patents
  12. Legal matters
  13. Clinical trials

Israeli Health Minister moves to lift surrogacy restrictions for singles and gay couples

The Israeli Health Minister has announced a new Bill allowing homosexual men and women and unmarried people the right to access surrogacy services within Israel. The new Bill permits single men and women and homosexual men and women to use a surrogate in Israel providing that their own sperm or eggs are used in conception and will increase the availability of surrogates by relaxing the criteria by which women can act as surrogates. Heterosexual couples will be eligible for up to two children born through surrogacy, but single parents would be restricted to one. Currently, unmarried men and women must go abroad if they wish to use a surrogate.

Filipino government cuts all funding for modern contraceptives

The President of the Philippines is reported as recently having passed a national budget that has cut all public funding for modern contraceptive services within the Philippines. This comes just 1 year after the President signed the Responsible Parenthood and Reproductive Health Act 2012 which was to have guaranteed universal and free access to modern contraceptives for all citizens. The 2012 Act was, however, challenged in the courts and the Filipino Supreme Court issued a temporary restraining order to allow Judges to debate the constitutionality of the new law. The Court has still to make an official judgement on this issue. It is estimated that 11 women die each day from pregnancy-related complications and 475 000 illegal abortions are performed each year as a result of the extreme anti-reproductive healthcare policies on restricting contraception and criminalising abortion in the Philippines.

Clinical trials

  1. Top of page
  2. E-cigarettes
  3. UK sexual practices
  4. Hospitalisation and venous thromboembolism in pregnancy
  5. Autism and selective serotonin reuptake inhibitors in pregnancy
  6. Multiple pregnancies in the USA
  7. Childhood obesity and pregnancy
  8. Postmenopausal hormones and cognitive function
  9. Cervical screening—USA 2014
  10. New reports and guidelines
  11. Innovations and patents
  12. Legal matters
  13. Clinical trials

Clinicians keen to keep up-to-date regarding clinical studies that are currently recruiting may find the following informative.■

Motherhood and microbiome (M&M)
Registration http://clinicaltrials.gov/ct2/show/NCT02030106
Description This prospective cohort study aims to investigate the role of cervicovaginal microbiota in spontaneous preterm birth. Women will be recruited during routine obstetric visits and will be asked to participate in three visits at 16–20 weeks, 20–24 weeks and 24–28 weeks of gestation. During each visit a vaginal swab will be taken and the women will be asked to complete a series of surveys assessing stress, anxiety and depression during pregnancy.
Outcome measures Primary: Cervicovaginal microbiota in women with and without preterm birth.Secondary: Potential modifiers of the cervicovaginal microbiome: behavioural factors, stress, nutrition/obesity, vaginal infections, genetic or host immune differences, race and ethnicity, social behaviors, environmental influences.
Study site Pennsylvania, USA.Anticipated study end date: July 2017.
Outcome of women with cervical cancer
Registration http://clinicaltrials.gov/ct2/show/NCT02026648
Description This observational study aims to retrospectively investigate the clinicopathological parameters and outcomes in women with squamous cell carcinoma (SCC) and adenosquamous carcinoma (AC) of the uterine cervix. The investigators hypothesise that as SCC and AC behave differently, new treatment strategies specifically designed to target AC should be developed.
Outcome measures Primary: Outcome of women with cervical cancer.Secondary: Not specified.
Study site Banqiao, Taiwan.Anticipated study end date: January 2015.
Titrated oral misoprostol compared to vaginal dinoprostone for induction of labor
Registration http://clinicaltrials.gov/ct2/show/NCT02036437
Description This randomised controlled trial aims to assess the safety and efficacy of titrated oral misoprostol (20–40 μg every 2 hours to a maximum of 12 hours) compared with vaginal dinoprostone (3 mg every 6 hours to a maximum of two doses) for induction of labour.
Outcome measures Primary: Induction delivery interval.Secondary: Women delivering their offspring vaginally within the first 24 hours; time from start of labour augmentation by either misoprostol or oxytocin to active phase of labour; duration of first, second and third stages of labour; maternal complications; mode of delivery; neonatal outcome.
Study site Cairo, Egypt.Anticipated study end date: September 2015.
Laminaria compared to Dilapan-S for cervical preparation before dilation and evacuation at 18–24 weeks of gestation
Registration http://clinicaltrials.gov/ct2/show/NCT02033083
Description This randomised controlled trial aims to investigate the difference between overnight cervical preparation with either laminaria or Dilapan-S™ on dilatation and evacuation (D&E) procedure time in women requiring second-trimester termination of pregnancy.
Outcome measures Primary: Time taken for dilatation and evacuation procedure.Secondary: Initial cervical dilatation before D&E; need for mechanical dilatation to accomplish D&E and ease of dilatation if required; number of osmotic dilators placed; ability to complete the D&E procedure without further cervical preparation; complications; pain and other side effects; patient acceptability; and provider acceptability.
Study site New York, USA.Anticipated study end date: June 2015.
Sleep apnea, obesity and pregnancy (GOS)
Registration http://clinicaltrials.gov/ct2/show/NCT02029859
Description This observational study aims to determine, in severe obese pregnant women (body mass index > 35), the prevalence of obstructive sleep apnoea syndrome in late pregnancy (after 30 weeks of gestation). All women will receive a polygraphic examination between 30 and 36 weeks of gestation.
Outcome measures Primary: Prevalence of sleep apnoea syndrome.Secondary: Not specified.
Study site Various locations, France.Anticipated study end date: March 2015.