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Elective preterm birth for fetal gastroschisis

  1. Natalie H Grant1,
  2. Jon Dorling2,
  3. Jim G Thornton3,*

Editorial Group: Cochrane Pregnancy and Childbirth Group

Published Online: 5 JUN 2013

Assessed as up-to-date: 16 JAN 2013

DOI: 10.1002/14651858.CD009394.pub2


How to Cite

Grant NH, Dorling J, Thornton JG. Elective preterm birth for fetal gastroschisis. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD009394. DOI: 10.1002/14651858.CD009394.pub2.

Author Information

  1. 1

    Nottingham University Hospitals NHS Trust, Department of Obstetrics and Gynaecology, Nottingham, Nottinghamshire, UK

  2. 2

    Nottingham City Hospital, Neonatal Medicine, Nottingham, UK

  3. 3

    University of Nottingham, Department of Obstetrics and Gynaecology, Nottingham, Nottinghamshire, UK

*Jim G Thornton, Department of Obstetrics and Gynaecology, University of Nottingham, Nottingham City Hospital NHS Trust, Hucknall Road, Nottingham, Nottinghamshire, NG5 1PB, UK. jim.thornton@nottingham.ac.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 5 JUN 2013

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Characteristics of included studies [ordered by study ID]
Logghe 2005

MethodsRandomised controlled trial.


ParticipantsThere were 44 eligible women. These included all women referred to a single tertiary fetomaternal medicine centre before 34 weeks' gestation with a sonographically diagnosed fetal gastroschisis. 42 women were randomised, 21 women to planned early birth at 36 weeks' gestation and 21 women to await spontaneous labour.


Interventions1. Elective birth at 36 weeks' gestation.

2. Await spontaneous labour, or need for elective birth for another reason.

Mode of birth was not prescribed by the trial in either group.


OutcomesPrimary outcome measures were time taken to achieve full enteral feeding and duration of hospital stay.


Notes1 baby in each arm died in utero before 36 weeks, at 33 weeks in the elective group and at 31 weeks in the spontaneous group. These 2 babies were excluded from analysis post-randomisation, and 40 babies were included in the final statistical analyses. Maternal outcome data for all 42 births were reported.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom numbers used and kept by a clinical trials unit.

Allocation concealment (selection bias)Low riskTelephone contact for allocation.

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding not possible but unlikely to affect outcomes/results. Surgeons were blinded to timing and mode of birth.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated whether outcome assessors were blinded to interventions.

Incomplete outcome data (attrition bias)
All outcomes
Low risk1 baby excluded from each group for intrauterine death post randomisation but before 36 weeks' gestation and for similar reasons (see Characteristics of included studies).

Selective reporting (reporting bias)Low riskAccording to trial report, all primary outcomes were reported.

Other biasLow riskNo other obvious sources of bias. However, the trial was not registered.

 
Comparison 1. Planned preterm birth versus planned later birth

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Stillbirth142Risk Ratio (M-H, Fixed, 95% CI)1.0 [0.07, 14.95]

 2 Fetal death before discharge140Risk Ratio (M-H, Fixed, 95% CI)5.0 [0.26, 98.00]

 3 Caesarean section142Risk Ratio (M-H, Fixed, 95% CI)0.78 [0.36, 1.70]

 4 Birthweight140Mean Difference (IV, Fixed, 95% CI)26.00 [-247.75, 299.75]

 5 Days of ventilation140Mean Difference (IV, Fixed, 95% CI)0.60 [-0.65, 1.85]

 6 Necrotising enterocolitis140Risk Ratio (M-H, Fixed, 95% CI)0.25 [0.03, 2.05]

 7 Non-primary closure (need for repeat surgery)140Risk Ratio (M-H, Fixed, 95% CI)0.75 [0.19, 2.93]

 8 Gestational age at birth (non-prespecified outcome)140Mean Difference (IV, Fixed, 95% CI)-0.90 [-1.63, -0.17]

 
Table 1. Additional neonatal outcomes (not specified in protocol)

OutcomeElective group (n = 20)Spontaneous group (n = 20)

Mean gestational age at birth (weeks)35.8 (SD 0.7)36.7 (SD 1.5)

Median age at operation (hours)2 (range 1-5)2.5 (range 1-4)

Bowel atresia42

Ventilated1918

Median duration of parenteral nutrition in survivors (days)22 (range 14-87)28 (range 12-346)

Median time to full enteral feeding in survivors (days)30.5 (range 18-96)37.5 (range 15-358)

Median time to hospital discharge in survivors (days)47.5 (range 23-126)53 (range 22-399)

 SD: standard deviation
 
Table 2. Additional maternal outcomes (not specified in protocol)

OutcomeElective group (n = 21)Spontaneous group (n = 21)

Mean age (years)23.3 (SD 6.2)22 (SD 4.6)

Gestational age at diagnosis (weeks)19 (range 14-22)18 (range 15-21)

Birth before 36 weeks' gestation44

 SD: standard deviation