Status:
UNKNOWN
To Study the Efficacy and Safety of Misoprostol by Sublingual Routes for Induction of Labour
Lead Sponsor:
Ministry of Health, Bhutan
Conditions:
Induction of Labour
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This research is to compare the efficacy and the safety of sublingual misoprostol with vaginal misoprostol administration for the induction of labour for primigravida at 41 or more weeks of pregnancy....
Detailed Description
Induction of labour is an intervention intended to artificially initiate uterine contraction in pregnant women who are not in labour. It is a common practice to interrupt the pregnancy at 41 weeks of ...
Eligibility Criteria
Inclusion
- Age 18 or more years
- Primigravida
- Singleton pregnancy
- Gestation at 41 or more weeks of pregnancy
- Estimated fetal weight of \<4000 gram
- In cephalic presentation
- Bishop score \< 6 (unfavorable cervix)
- Reassuring fetal heart rate tracing
Exclusion
- Age \<18 years
- Multiple pregnancy (twin, triplet and higher order pregnancies)
- Gestation \<41 weeks of pregnancy
- Fetal macrosomia (Estimated fetal weight \>4000 gram)
- Cephalo-pelvic disproportion
- Malpresentation (breech, oblique, transverse)
- Bishop score \>6 (favorable cervix)
- Presence of labor or uterine contractions
- Non-reassuring fetal heart rate tracing
- Pregnant women with known allergy to misoprostol,
- Previous Caesarean delivery or other uterine surgery
- Previous uterine rupture
- Placenta previa
- Chorioamnionitis
- Prelabour rupture of membrane (PROM)
- Antepartum hemorrhage (per vaginal bleeding)
- Contraindication to vaginal birth
- Medical disorders in pregnancy
- Active genital herpes infection
- Invasive cervical carcinoma
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2021
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04887493
Start Date
June 1 2021
End Date
November 30 2021
Last Update
May 17 2021
Active Locations (1)
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1
Phuentsholing Hospital
Phuentsholing, Bhutan, 21002