The Misoprostol Vaginal Insert for Labour Induction

Labour Induction Clinical Trial

Official title:

The Misoprostol Vaginal Insert Used in Standard Compared With Adjusted Criteria for Labour Induction in Term Pregnancies: a Non-interventional Case Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03016208
• Other study ID #: Miso2017
• Status: Completed
• Phase: N/A
• First received: January 8, 2017
• Last updated: January 9, 2017
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: Asklepios Kliniken Hamburg GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) for labour induction using standard (MVI-24) and adjusted (MVI-10) criteria.

Design: Non-interventional observational case control study.

Setting: Tertiary-care academic centre in Germany.

Population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.

Methods: Induction of labour with MVI in a consecutive series of women using standard (MVI-24, n = 69) or adjusted (MVI-10, n = 69) criteria.

Main outcome measures: The primary outcomes were the time from induction to delivery and the caesarean section rate. The secondary outcomes included the need for additional measures to induce labour, uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• gynecologist'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 praevia

• chorioamnionitis

• antepartum bleeding of unknown etiology

• cardiopulmonary, renal, hepatic maternal disease

• glaucoma

• fetal congenital abnormalities

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Labour Induction

Intervention

Drug:
• Misoprostol vaginal insert

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asklepios Kliniken Hamburg GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from induction to delivery in minutes		August 2016	No
Primary	Rate of participants receiving a caesarean section compared to all participants being induced		August 2016	Yes
Secondary	Number of participants with treatment-related tachysystole as assessed by cardiotocography		August 2016	Yes
Secondary	Number of participants with treatment-related adverse events following tocolysis with Partusisten		August 2016	Yes
Secondary	Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value		August 2016	Yes