USE OF AN OPD DRUG TO PREVENT PROLONGED PREGNANCY

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/09/005006
• Date of registration: 11-09-2014
• Prospective Registration: No
• Primary sponsor: University College of Medical Sciences and Guru Teg Bahadur HOSPITAL
• Public title: USE OF AN OPD DRUG TO PREVENT PROLONGED PREGNANCY
• Scientific title: OUTPATIENT-BASED MISOPROSTOL TO PREVENT PROLONGED PREGNANCY
• Date of first enrolment: 13-10-2011
• Target sample size: 130
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=7680
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: NIKITA JINDAL
• Affiliation: DEPARTMENT OF OBG, UCMS & GTB HOSPITAL

• Name: NEELAM VAID
• Affiliation: DEPARTMENT OF OBG, UCMS & GTB HOSPITAL

Key inclusion & exclusion criteria

Inclusion criteria: Total number of 130 subjects of uncomplicated singleton pregnancy at 40 completed weeks (gestational age based on LMP or scan before 20 weeks of gestation) of gestation with vertex presentation with Bishop score ï?£5.

• Intact membranes or no leaking per-vaginum

• No contraindication for vaginal delivery

• Normal Biophysical profile


Exclusion criteria: • Grand multiparity (ï?³5)

• Any maternal systemic disease

• Previous LSCS / uterine scar

• Unexplained vaginal bleeding

• EFW >3.5 kg

• Fetal growth restriction, oligohydramnios (AFI ï?£5)

• Fetal anomalies

• Contraindications for misoprostol (allergy, cardiovascular diseases, renal impairment etc.)



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- uncomplicated singleton pregnant women at 40 weeks of gestation

Intervention(s)

Intervention1: Misoprostol: Single low dose (25 µg) misoprostol vaginally given on outpatient basis at 40 completed weeks of gestation
Control Intervention1: nil: no intervention

Primary Outcome(s)

â?¢ Number of women entering spontaneous labor between 40 to 41 weeks of gestationTimepoint: 41 weeks of gestation or spontaneous labor (which ever is earlier)

Secondary Outcome(s)

â?¢ Time from enrolment in study till delivery

â?¢ Need for cesarean section

â?¢ Neonatal outcome in early neonatal age (Apgar score at 1 and 5 minutes, meconium stained liquor, neonatal morbidity and mortality)

â?¢ Side effects of misoprostol in mother (nausea, vomiting, diarrhea, fever and abnormal uterine activity, etc.)

Timepoint: one week

Secondary ID(s)

NIL

Source(s) of Monetary Support

UCMS, GTB HOSPITAL

Ethics review

Status: Approved
Approval date: 03/12/2012
Contact:

Institutional Ethics Committee - Human Research