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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06343480
Other study ID # SMVOT2024CT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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