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

NCT ID: NCT06343480

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-11-30

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.

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.

Conditions

Labor Onset and Length Abnormalities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

first arm - Oxytocin titration

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

Group Type: ACTIVE_COMPARATOR

Labour Induction

Intervention Type: DRUG

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

second arm - Misoprostol give sublingual

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

Group Type: ACTIVE_COMPARATOR

Labour Induction

Intervention Type: DRUG

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

Interventions

Labour Induction

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

Intervention Type: DRUG

Other Intervention Names

oxytocin titration

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal Teaching Hospital Abakaliki

OTHER_GOV

Sponsor Role: lead

Responsible Party

Nwali Matthew Igwe

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, Nigeria

Federal Teaching Hospital, Abakaliki

Abakaliki, Ebonyi State, Nigeria

Countries

Nigeria

Other Identifiers

SMVOT2024CT

Identifier Type: -

Identifier Source: org_study_id