Witter 1987.
Study characteristics | ||
Methods | RCT | |
Participants | Number of women randomised: 200
Setting: Baltimore, USA Study date: not reported Inclusion criteria
Exclusion criteria No additional criteria reported State of cervix: not mentioned |
|
Interventions |
Induction group (n = 103): oxytocin infusion with AROM when possible
versus EM group (n = 97): Estriol measurements 2‐3/week. In both groups women initiated fetal movement counting. If reduced fetal movements, FHR and estriol testing were undertaken at 41 completed weeks. |
|
Outcomes | Mother: GA at birth; length of hospital stay; urinary estriol/creatinine ratio; maternal complications; endometritis; pre‐eclampsia; PROM; caesarean section + indications Baby: birthweight; biparietal diameter; placental weight; Dubowitz score (assesses infant GA); SGA/AGA/LGA; fetal distress; meconium staining; infant complications; Apgar scores (< 7 at 5 minutes); fetal anomalies; post‐mature infants; meconium aspiration | |
Notes |
Funding: not reported Declarations of interest: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The randomisation sequence was generated using a computer‐generated random number table. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was achieved using sequentially labelled sealed envelopes, but there was no mention of opaqueness. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Appeared that blinding was not feasible |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinded outcome assessment was not mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3/103 women and 2/97 women in the induction and EM groups dropped out of the study; 35/103 women and 39/97 in the induction and EM groups birthing prior to 42 completed weeks (and were included); all were included in the analyses. |
Selective reporting (reporting bias) | Unclear risk | No detailed outcomes were prespecified in the methods; perinatal death was not reported. No access to trial protocol to further assess selective reporting |
Other bias | Low risk | Appeared to be free of other bias |
AGA: appropriate for gestational age; AROM: artificial rupture of membranes/amniotomy; CTG: cardiotocography; EBL: estimated blood loss; EFW: estimation of fetal weight; EM: expectant management; FHR: fetal heart rate; GA: gestational age; HIE: hypoxic ischaemic encelopathy; HIV: human immunodeficiency virus; IOL: induction of labour; IND: induction; ITT: intention to treat; IU: international units; IUFD: intrauterine fetal death IUGR: intrauterine fetal growth restriction IV: intravenous; IVF: in‐vitro fertilisation; LGA: large‐for‐gestational age; LMP: last menstrual period mIU: milli‐international units; mU: milli‐units; NICU: neonatal intensive care unit; NST: nonstress test; PGE2 (and PE2): prostaglandin E2; PROM: premature rupture of membranes; RCT: randomised controlled trial; ROM: rupture of membranes; SGA: small‐for‐gestational age