Labour Induction Clinical Trial
Official title:
The Misoprostol Vaginal Insert Compared With Oral Misoprostol for Labour Induction in Term Pregnancies: a Pair-matched Case-control Study
Verified date | September 2016 |
Source | Asklepios Kliniken Hamburg GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) with
an off-label use of oral misoprostol (OM).
Design: Pair-matched case-control study.
Setting: Tertiary-care academic centre in Germany.
Population: A cohort of 138 women ≥ 37/0 weeks pregnant undergoing labour induction.
Methods: The induction of labour with a retrievable prostaglandin vaginal insert in a
consecutive series of 69 women was compared with induction using oral misoprostol in a
pair-matched cohort.
Main outcome measures: The primary outcomes were the time from induction to delivery and the
caesarean section rate. Secondary outcomes included uterine tachysystole, tocolysis, fetal
scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar
score.
Status | Completed |
Enrollment | 138 |
Est. completion date | January 2016 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - gynaecologist's indication for induction - informed consent - > 37 weeks of gestation - singleton pregnancies - cephalic presentation - cervical Bishop score of < 5 before priming reassuring fetal heart rate Exclusion Criteria: - known hypersensitivity to prostaglandins - uterine scar - parity > 5 - any contraindication for vaginal delivery - cephalopelvic disproportion - placenta previa - chorioamnionitis - antepartum bleeding of unknown aetiology - cardiopulmonary, renal, hepatic maternal disease glaucoma - fetal congenital abnormalities |
Observational Model: Case Control
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Asklepios Kliniken Hamburg GmbH |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | time from application of the medication until delivery in minutes | September 2015 | No | |
Secondary | Rate of participants receiving a caesarean section compared to all participants being induced | September 2015 | Yes | |
Secondary | Number of participants with treatment-related tachysystole as assessed by cardiotocography | September 2015 | Yes | |
Secondary | Number of participants with treatment-related adverse events following tocolysis with Partusisten | September 2015 | Yes | |
Secondary | Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value | September 2015 | Yes |
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