Clinicians keen to keep up-to-date regarding clinical trials that are currently recruiting may find the following informative.
Trial of use of injectable progestin (DMPA) injection and high-dose oral progestin (MPA) tablets in outpatient treatment of acute excessive vaginal bleeding
This pilot clinical trial of 50 women aims to investigate the effectiveness of short-term administration of 20-mg medroxyprogesterone acetate (MPA) tablets three times a day for 3 days combined with the injectable progestin (depot MPA; DMPA) that lasts for 3 months. Women will be followed up at 24 and 48 hours to report bleeding status, their use of medication and any side effects. On day 3, women will return to the clinic for a repeat haemoglobin and interval test. Women who continue to bleed on day 3 will be contacted again on day 5.
Inclusion criteria: women aged 18–50 years; candidates for outpatient management; vital signs stable; no severe anaemia; no medical conditions requiring transfusion.
Primary outcome measure: slowing of acute bleeding.
Secondary outcome measures: complete cessation of bleeding; compliance with study medication.
Trial site: California, USA.
Anticipated trial end date: October 2010.
The biomarker study
This cohort study will assess women at risk for preterm birth secondary to preterm labour, preterm prelabour rupture of membranes (PPROM) and cervical insufficiency. A medical/obstetric history will be obtained as well as four samples of maternal blood (collected on separate occasions), samples of placental cord blood, maternal saliva and an infant buccal swab. Each woman’s pregnancy outcome will be followed to identify correlations between biomarker levels, latency to delivery and adverse neonatal outcomes.
Inclusion criteria: women with singleton pregnancies (22+0 to 33+6 weeks) who present to the Hospital of the University of Pennsylvania (HUP) ‘Perinatal Evaluation Center’ with preterm labour, PPROM or cervical insufficiency; women who present in labour and deliver (or have just delivered) a single preterm infant (22+0 to 33+6 weeks) at HUP.
Trial site: Pennsylvania, USA.
Anticipated trial end date: June 2012.
Effects of exercise for overweight women with polycystic ovary syndrome (POLY)
This interventional, non-randomised trial aims to assess the effects of a 16-week exercise training programme on insulin resistance and adiposity in overweight/obese women with polycystic ovary syndrome (PCOS). A number of baseline assessments will be performed: the control group will undergo these assessments once and the PCOS group will undergo them twice, once at baseline and once after 16 weeks. During the 16-week exercise programme, body weight will be measured weekly and menstrual cycle frequency will be documented.
Inclusion criteria: women aged 18–30 years; BMI ≥ 25; sedentary lifestyle, not currently exercising >60 minutes/week; medical diagnosis of PCOS; non-PCOS controls are required to have regular menstrual cycles (one per month).
Primary outcome measure: change in insulin sensitivity measured by the euglycaemic–hyperinsulinaemic clamp.
Secondary outcome measures: change in visceral fat, body lipolysis and menstrual cyclicity.
Trial site: Louisiana, USA.
Anticipated trial end date: June 2011.
Postoperative belladonna and opium suppositories in vaginal surgery
This randomised, interventional trial aims to determine the effectiveness of belladonna and opium suppositories in improving pain control following vaginal surgery. Treatment will be administered immediately after surgery and will continue every 8 hours for 24 hours.
Inclusion criteria: scheduled for elective vaginal surgery requiring general anaesthesia at the Mayo Clinic Hospital.
Primary outcome measure: pain at hour 4 (linear analogue scale score for pain at 4 hours after surgery).
Secondary outcome measures: pain at hours 12 and 20 (linear analogue scale score for pain at hours 12 and 20 after surgery).
Trial site: Arizona, USA
Anticipated trial end date: June 2012.
US 7740849 Use of compounds that bind soluble endoglin and SFLT-1 for the treatment of pregnancy-related hypertensive disorders. This US granted patent is for treating pregnancy-related hypertensive disorders. The inventors have discovered that both soluble endoglin levels in placental tissue samples and soluble endoglin protein levels in serum are elevated in women with a pregnancy-associated hypertensive disorder. This invention proposes that compounds that bind to or neutralise soluble endoglin can be used to reduce the elevated levels of soluble endoglin and treat pregnancy-associated hypertension, including pre-eclampsia and eclampsia. See Annu Rev Pathol 2010;5:173–92 for an excellent review by the same group of authors on placental antiangiogenic factors in pre-eclampsia.
Karumanchi S, Sukhatme VP, Toporsian M, Letarte MV. Use of compounds that bind soluble endoglin and SFLT-1 for the treatment of pregnancy-related hypertensive disorders. 22 June 2010.
EP 1677875 B1 A protein involved in ovarian cancer. This European granted patent claims an anti-CDCP1 antibody for use in the treatment, prophylaxis, screening or diagnosis of ovarian cancer. CDCP1 is a transmembrane protein with intracellular tyrosine residues that are phosphorylated upon activation; it is supposed to be engaged in proliferative activities and resistance to apoptosis of cancer cells.
Burgess NA. A protein involved in ovarian cancer. 9 June 2010.
US 2010/0150862 A1 Methods of modulating maternal–fetal tolerance. This application provides cytokines and methods of modulating maternal tolerance and implantation of a fetus using interleukin-27, a heterodimeric cytokine involved in cell-mediated immunity. A method of determining whether an individual is suffering from immune-mediated spontaneous abortion is also claimed.
Devergne, O. Methods of modulating maternal–fetal tolerance. 17 June 2010.
US 2010/0152102 A1 Use of somatostatin or one of its analogues for preparing a medicament intended to regulate the ovarian follicular reserve in nonmenopausal women. This patent application relates to the use of somatostatin agonist analogues to produce a treatment to regulate ovarian follicular reserve in nonmenopausal women by reducing the depletion of the reserve over time or by using such compounds to accelerate the start of the growth of quiescent follicles. In a recent publication, the same group shows that, in the mammalian ovary, kit ligand, coded by a cAMP-stimulatable gene, is a protein that promotes initiation of follicle growth. The neuropeptide somatostatin is a small peptide that inhibits cAMP generation in many cell types. Consequently, somatostatin receptor agonists might alter kit ligand production and subsequent follicle growth (Endocrinology 2010;151:1299–309).
Gougeon, A., Loumaye, E. Use of somatostatin or one of its analogues for preparing a medicament intended to regulate the ovarian follicular reserve in nonmenopausal women. 17 June 2010.
US 2010/0154801 A1 Method of surgical repair if vagina damaged by pelvic organ prolapse and prosthetic materials and devices suitable for use therein. This patent application relates to a method, using various prosthetic materials and devices, for surgical repair of the vaginal wall that has been damaged by the prolapse of any of the pelvic organs. Specifically, the vaginal wall can be repaired by first mobilising the vaginal epithelium off the underlying fascia of at least part of the vaginal wall, then positioning a prosthetic material over the exposed fascia, followed by re-fixing the vaginal epithelium over the prosthetic material and fascia, and finally inserting an intravaginal splint in the vagina.
Carey, M. Method of surgical repair if vagina damaged by pelvic organ prolapse and prosthetic materials and devices suitable for use therein. 24 June 2010.
Ohio senate bill proposes ‘hybrid’ ban
The Ohio State Senate in the USA has recently passed Bill 243, banning the creation of any embryo that would contain both human and animal DNA or tissues. The bill lists eight different ‘human–animal hybrids’, used in stem cell research, that would become illegal. The bill has now been sent to the State House of Representatives for deliberation.
African women still not getting justice in National Courts
A new report, published in June, highlights the fact that women in African Commonwealth countries are not receiving adequate protection from national courts. The report analyses African Commonwealth court cases over the past decade and concludes that the courts have failed to protect women, particularly in cases of sexual violence, child custody and marital disputes, despite guaranteeing those rights in local egislation and within regional and international agreements.