The Misoprostol Vaginal Insert for Labour Induction

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03016208

Enrollment

138

Registered

2017-01-10

Start date

2015-05-31

Completion date

2016-05-31

Last updated

2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labour Induction

Brief 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.

Interventions

DRUGMisoprostol vaginal insert

Study design

Observational model

COHORT

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time from induction to delivery in minutes	August 2016
Rate of participants receiving a caesarean section compared to all participants being induced	August 2016

Secondary

Measure	Time frame
Number of participants with treatment-related tachysystole as assessed by cardiotocography	August 2016
Number of participants with treatment-related adverse events following tocolysis with Partusisten	August 2016
Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value	August 2016

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026