To Study the Efficacy and Safety of Misoprostol by Sublingual Routes for Induction of Labour

NCT04887493 | Unknown

• 2 other identifiers: Sublingual misoprostolIOL
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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. In routine practice, misoprostol 25µg is used by per vaginal route for the induction of labour in Bhutan. The misoprostol dose is given repeatedly every 4 hours to a maximum of 6 dosages. The per vaginal route is found to be very effective and safe for the induction of labour. But, patient compliance is poor and increasing the risk of neonatal sepsis since it has to be inserted into vagina every 4 hours. To overcome these problems with per vaginal route, this study is developed to explore the efficacy and safety of misoprostol use by sublingual routes for the induction of labour. Misoprostol can be used by sublingual, oral or per vaginal route as per the findings of the other studies. If the finding of this study proves sublingual use of misoprostol is safe and efficient for the induction of labour, the current practice of using misoprostol by vaginal route will be changed to sublingual route in Bhutan.

Conditions

Induction of Labour

Keywords

Induction of labour; Sublingual misoprostol; Vaginal misoprostol; Vaginal delivery

Outcome Measures

Primary Outcomes (1)

• To measure the number of pregnant mothers who have a vaginal delivery within 24 hours of the induction.

  The number of successful vaginal deliveries will be recorded and compared between the study arms. This is to study the overall efficacy of sublingual use of misoprostol in compared between the study group

  The numbers of successful vaginal delivery conducted in each group will be measured for 6 months.

Secondary Outcomes (3)

• To compare the dosages of misoprostol required for induction of labour in the study arms.

  The total number of repeat dosages of misoprostol use in the each study participant will be determined for 24 hours.

• The modes of delivery will be compared between the study arms

  The individual modes of delivery will be documented for 24-48 hours

• To compare the induction to delivery interval between the study group

  The time taken from the starting of the induction to the time at delivery will be measured for individual study participant for 24 - 48 hours.

Study Arms (2)

Sublingual misoprostol

EXPERIMENTAL

Sublingual misoprostol group will receive misoprostol 25µg by sublingual routes; the dose will be given repeatedly every 4 hours by sublingual route till there is labour pain or contraction or to a maximum of 6 dosages.

Drug: Misoprostol

Vaginal misoprostol

EXPERIMENTAL

Vaginal misoprostol group will receive misoprostol 25µg by per vaginal routes; the dose will be given repeatedly every 4 hours by per vaginal route till there is labour pain or contraction or to a maximum of 6 dosages.

Drug: Misoprostol

Interventions

Misoprostol DRUG

Misoprostol 25µg will be used for both the study arms

Also known as: Prostaglandin E1

Sublingual misoprostol; Vaginal misoprostol

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The person with female gender gets pregnant. A male person is not compatible to get pregnant. The study will recruit only those pregnant mothers who need induction of labour.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ministry of Health, Bhutan: lead

Study Sites (1)

Phuentsholing Hospital

Phuentsholing, 21002, Bhutan

Location

Related Publications (3)

• Teixeira C, Lunet N, Rodrigues T, Barros H. The Bishop Score as a determinant of labour induction success: a systematic review and meta-analysis. Arch Gynecol Obstet. 2012 Sep;286(3):739-53. doi: 10.1007/s00404-012-2341-3. Epub 2012 May 1.

  PMID: 22546948 BACKGROUND

• Batinelli L, Serafini A, Nante N, Petraglia F, Severi FM, Messina G. Induction of labour: clinical predictive factors for success and failure. J Obstet Gynaecol. 2018 Apr;38(3):352-358. doi: 10.1080/01443615.2017.1361388. Epub 2017 Oct 23.

  PMID: 29058493 BACKGROUND

• Mozurkewich EL, Chilimigras JL, Berman DR, Perni UC, Romero VC, King VJ, Keeton KL. Methods of induction of labour: a systematic review. BMC Pregnancy Childbirth. 2011 Oct 27;11:84. doi: 10.1186/1471-2393-11-84.

  PMID: 22032440 BACKGROUND

MeSH Terms

Interventions

Misoprostol; Alprostadil

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Prostaglandins E; Fatty Acids, Monounsaturated

Study Officials

• Yeshey Dorjey

  Ministry of Health, Phuentsholing Hospital, Chukha, Bhutan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeshey Dorjey, MS

CONTACT

+97577293881; yesheydorjey@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participants and the investigators will not be masked; however, outcome assessor (statisticians) will be masked because they will not know anything about the drugs received by sublingual or per vaginal routes as their role will be to analyze the outcome only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pregnant mothers at term (37 - 42 weeks of gestation) and post term (\>42 weeks of gestation) admitted to gynecology ward for induction of labour will be recruited to the study. The enrolled pregnant mothers will be randomly assigned to two groups by lottery method. Group 1- will be receive misoprostol 25µg by sublingual route for induction of labour; Group 2- will receive misoprostol 25µg by per vaginal route.

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 14, 2021
• Study Start: June 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BH (1)