Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
825 participants
INTERVENTIONAL
2002-12-31
2010-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Double-balloon
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.
Double Balloon
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.
Prostglandin E2
The prostaglandin 2 minprostin (3mg) was applied vaginally
Minprostin
The prostaglandin 2 minprostin (3mg) was applied vaginally
Interventions
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Double Balloon
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.
Minprostin
The prostaglandin 2 minprostin (3mg) was applied vaginally
Eligibility Criteria
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Inclusion Criteria
* 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
* placenta previa
* acute fetal distress
* specific infections vagina/cervix (GBS, condyloma, acute herpes)
* asthma
* glaucoma
* allergy to latex
FEMALE
No
Sponsors
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Glostrup University Hospital, Copenhagen
OTHER
Responsible Party
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Department obstetrics and gynecology
Locations
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Glostrup University Hospital
Glostrup Municipality, Glostrup, Denmark
Countries
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Other Identifiers
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H-KA-01177-M
Identifier Type: -
Identifier Source: org_study_id