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

Labor Onset and Length Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06343480
• Other study ID #: SMVOT2024CT
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2024
• Source: Federal Teaching Hospital Abakaliki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Onset and Length Abnormalities
• Rupture
• Rupture, Spontaneous

Intervention

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

Locations

Country	Name	City	State
Nigeria	Alex Ekwueme Federal University Teaching Hospital	Abakaliki	Ebonyi
Nigeria	Federal Teaching Hospital, Abakaliki	Abakaliki	Ebonyi

Sponsors (1)

Lead Sponsor	Collaborator
Federal Teaching Hospital Abakaliki

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean induction delivery interval	the time take from start of induction to the time of delivery of the fetus.	During the delivery