Misoprostol Versus Oxytocin for Induction of Labour in Parturients With Spontaneous Rupture of Fetal Membranes at Term

Sublingual Misoprostol Versus Oxytocin Titration for Induction of Labour in Parturients With Spontaneous Rupture of Fetal Membranes at Term: A Randomised Controlled Tial.

Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment. This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term Prelabour Ruptuture of Membranes.

Study Overview

• Status: Completed
• Conditions: Labor Onset and Length Abnormalities
• Intervention / Treatment: Drug: Labour Induction

Detailed Description

Induction of labour for term premature rupture of fetal membranes (PROM) is associated with greater maternal satisfaction and lower risk of maternal infection compared with expectant management. The ideal method of induction of labour for term PROM is a subject of controversy. Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment.

This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term PROM. This was a double blind randomized controlled trial on the efficacy of sublingual misoprostol versus oxytocin titration in women with term PROM at the Alex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA) and Mile 4 Hospital Abakaliki. 240 Participants were divided into two groups of 120 participants each. Group A received 25 mcg of sublingual misoprostol and titration of 500 ml of Ringer's lactate solution as placebo with 5ml of sterile water injected into it while group B underwent immediate induction of labour with titration of 5 units of oxytocin in a 500 ml of Ringer's lactate solution and received one tablet of 100mg Vitamin C as placebo. The primary outcome measure was the mean induction delivery interval. The secondary outcome measures were Caesarean section rate, the incidence of uterine hyper-stimulation, tachysystole or hypertonus, APGAR scores at the first and fifth minute and NICU admission. Data analysis was done using statistical Package for Social Science (IBM SPSS) software (version 20, Chicago IL, USA). Continuous variables were presented as mean and standard deviation (Mean ± SD), while categorical variables were presented as numbers and percentages. Categorical variables were analyzed using Chi-square while means were compared using T-test. A difference with a P value of <0.05 was considered significant.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Ebonyi
    • Abakaliki, Ebonyi, Nigeria, 480001
      • Federal Teaching Hospital, Abakaliki
    • Abakaliki, Ebonyi, Nigeria, 480001
      • Alex Ekwueme Federal University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• signed informed consent
• singleton pregnancy at term
• prelabour rupture of membranes
• not having contraction
• Bishop scoe 5 or less

Exclusion Criteria:

• prelabour rupture of membranes at less than term
• declined consent
• contraindication for vaginal delivery
• multiple gestation
• medical conditions co-existing with pregnancy
• grand multiparous parturients
• previous caesarean section scar
• already having contractions
• has intrauterine foetal death
• bishop sore >5

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: first arm - Oxytocin titration; Received vitamin c 100mg as placebo and had Oxytocin titration in 500ml of ringers lactate for labour induction	Drug: Labour Induction; the use of misoprostol sublingual for labour induction compared with oxytocin titration in parturients with prelabour membrane rupture at term.; Other Names: oxytocin titration
Active Comparator: second arm - Misoprostol give sublingual; received 25mcg of Misoprostol and titration of plane 500ml of ringers lactate as placebo	Drug: Labour Induction; the use of misoprostol sublingual for labour induction compared with oxytocin titration in parturients with prelabour membrane rupture at term.; Other Names: oxytocin titration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean induction delivery interval	the time take from start of induction to the time of delivery of the fetus.	During the delivery

Collaborators and Investigators

• Sponsor: Federal Teaching Hospital Abakaliki

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pathological Conditions, Anatomical; Rupture; Rupture, Spontaneous; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: SMVOT2024CT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No