Caesarean Section Clinical Trial
Official title:
A Prospective Multi-centre Randomised Comparison on Induction of Labour With Double-balloon Installation Device Versus Prostaglandin E2 Minprostin
The use of prostaglandin E2 (PGE2) for induction of labour in women with unfavourable
cervices is well-established1. There are, however, potential side effects to prostaglandins,
in particular the risk of uterine hypertonicity which may affect fetal outcome. In theory a
mechanical ripening based on dilatation of the cervix as well as induction of production of
endogenous prostaglandin has potentially less influence on the fetal outcome but a Cochrane
review from 2001 scrutinized studies on mechanical ripening versus placebo/no treatment or
prostaglandin E2. They conclude there is insufficient data to evaluate the effectiveness in
terms of likelihood of vaginal delivery in 24 hours, and emphasise the need for large sample
size studies and substantive outcomes. Two later randomised studies compared mechanical
ripening to PGE2 and found discrepant results regarding time from induction to delivery.
The primary purpose of the present study was in a randomized design to compare the efficacy
of double-balloon catheter versus vaginal PGE2 (minprostin 3 mg) on induction of labour,
duration of birth and fetal outcome. Secondary analyses were to evaluate the results for
various subgroups, i.e. primipara/multipara, gemelli, vaginal birth after caesarean, preterm
birth and intra uterine growth restriction.
The study was a multicenter randomized study conducted at 7 labour yards in Denmark
(Glostrup, Hillerød, Svendborg, Rigshospitalet, Næstved, Frederiksberg and Hvidovre).
Participants were included from December 11 2002 till September 29 2005 after approval from
The Danish National Committee on Biomedical Research Ethics and the data legislation. All
participants were included after written and oral informed consent.
Eligible for inclusion were pregnancies with intact fetal membranes, vertex position and
unripe cervix (Bishop score < 6) who had usual indications for induction of labour, i.e.
prolonged pregnancy, pre-eclampsia/ hyper-tension, placental insufficiency, diabetes
mellitus and twins.
Women were excluded under the following circumstances: Spontaneous labour or rupture of
membranes, placenta previa, acute fetal distress, specific infections vagina/cervix (GBS,
condyloma, acute herpes), asthma, glaucoma and allergy to latex. The participants were
randomised to treatment arm by 'telephonic automatic voice response system randomisation'.
Induction of labour methods The balloon group The Double Balloon Catheter was applied (Atad
5) with 80 ml NaCl installed intrauterine above the intern orificium and 80 ml below in
cervix/vagina. The Balloon catheter was inserted in the evening (8-9 p.m.) if the
Bishop-score was below 6, however if the score was above 6 or the insertion was impossible
the participant was considered failure. The catheter was removed after 12 h (or before if
needed). The labour induction was continued by amniotomy either directly or after 2 hours
mobilisation and laxative or after additional 2 hours of intravenous syntocinon drip. If by
then amniotomy was not possible the participant was considered failure. After amniotomy if
necessary for progression of contractions intravenous oxytocin-drip was started for 2-3
hours (figure 1). If further induction was necessary the participant was considered failure.
The minprostin group The prostaglandin 2 minprostin (3mg) was applied vaginally in the
morning the day of induction if Bishop score was 6 or below. After 4-5 hours a second
minprostin was inserted if amniotomy was not possible. If the labour was not induced the
first day the procedure it was repeated the following day. If labour was not established
within 48 hours after the first minprostin the participant was considered failure.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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