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

NCT06343480 | Completed DMC

• 1 other identifier: SMVOT2024CT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Labor Onset and Length Abnormalities

Outcome Measures

Primary Outcomes (1)

• Mean induction delivery interval

  the time take from start of induction to the time of delivery of the fetus.

  During the delivery

Study Arms (2)

first arm - Oxytocin titration

ACTIVE COMPARATOR

Received vitamin c 100mg as placebo and had Oxytocin titration in 500ml of ringers lactate for labour induction

Drug: Labour Induction

second arm - Misoprostol give sublingual

ACTIVE COMPARATOR

received 25mcg of Misoprostol and titration of plane 500ml of ringers lactate as placebo

Drug: Labour Induction

Interventions

Labour Induction DRUG

the use of misoprostol sublingual for labour induction compared with oxytocin titration in parturients with prelabour membrane rupture at term.

Also known as: oxytocin titration

first arm - Oxytocin titration; second arm - Misoprostol give sublingual

Eligibility Criteria

• Age: 15 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Teaching Hospital Abakaliki: lead

Study Sites (2)

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, 480001, Nigeria

Location

Federal Teaching Hospital, Abakaliki

Abakaliki, Ebonyi State, 480001, Nigeria

Location

MeSH Terms

Interventions

Labor, Induced

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 2, 2024
• Study Start: September 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: November 30, 2021
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

NG (2)