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.
Status | Completed |
Enrollment | 825 |
Est. completion date | December 2010 |
Est. primary completion date | September 2005 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - pregnancies with intact fetal membranes - vertex position - unripe cervix Bishop score < 6) - usual indications for induction of labour, i.e. prolonged pregnancy, pre-eclampsia/ hyper-tension, placental insufficiency, diabetes mellitus and twins Exclusion Criteria: - Spontaneous labour or rupture of membranes - placenta previa - acute fetal distress - specific infections vagina/cervix (GBS, condyloma, acute herpes) - asthma - glaucoma - allergy to latex |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Denmark | Glostrup University Hospital | Glostrup |
Lead Sponsor | Collaborator |
---|---|
Glostrup University Hospital, Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | success of induction of labour, duration of birth and fetal outcome | 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) . | at birth | No |
Secondary | the results for various subgroups, i.e. primipara/multipara, gemelli, vaginal birth after caesarean, preterm birth and intra uterine growth restriction | at birth | No |
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