"SAFETY AND EFFICACY OF ORAL AND VAGINAL MISOPROSTOL FOR INDUCTION OF LABOUR IN TERM PREGNANCIESâ€- A RANDOMISED CONTROLLED TRIAL IN A TERTIARY HEALTH CENTRE

Phase 2

Recruiting

Conditions: Prolonged pregnancy,

Registration Number: CTRI/2019/09/021130

Lead Sponsor: MOSC MEDICAL COLLEGEKOLENCHERY

Brief Summary: Induction of labour implies stimulation of contractions before the spontaneous onset of labour, with or without ruptured membranes.[1].According to ACOG 2014[2],the risks and benefits of induction of labour were studied on caesarean section rate and trials showed no significant difference .Recent studies[3]- variation .i.e oral misoprostol for induction has comparatively decreased the incidence of Primary caesarean section for fetal distress. Primary caesarean which is a caesarean section done for the first time in pregnant woman.

Prostaglandins has been found to have a major role in cervical ripening and making it favourable for a vaginal delivery. Among them, Misoprostol [Synthetic PGE1 analogue] is commonly used. It is Stable at room temperature, Relatively inexpensive ,can be given via several routes -oral, vaginal, sublingual ,buccal, rectal. Misoprostol has a potential risk for hyperstimulation, which is defined as occurrence of uterine contraction lasting for >60secs ,OR >4 contractions in a 10 minute period regardless the state of the fetus. Therefore, it is necessary to be administered in titrated doses so that the risk can be reduced .This is the reason for inclusion of oral misoprostol as one of the recommended induction agents in the WHO EXPERT committee-Labour guidelines in 2011.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 154

Inclusion Criteria

Nulliparous and Multiparous women at term(37-42 completed weeks of gestation with first trimester ultrasound confirmed dates),with a singleton fetus of Cephalic presentation with : Clinically adequate pelvis Reassuring fetal heart tracing, ,Modified bishopâ€™s score of less than 6 [1]Gestational diabetes mellitus, [2] gestational hypertension, [3]past date, [4]oligohydramnios, [5]Premature rupture of membranes[<6hours] Are eligible for this trial.

Exclusion Criteria

All patients with [1]severe systemic illnesses like uncontrolled diabetes mellitus, severe pre-eclampsia, cardiac, renal or hepatic disease, [2] IUGR, [3]intrauterine deaths [4]hypersensitivity to misoprostol or any prostaglandin analogue [5] Patients with any contraindication to induction and vaginal delivery, e.g. cephalopelvic disproportion, malpresentation, fetal compromise, non reassuring fetal heart rate pattern, previous scar and ante partum haemorrhage.
[6] Patients who are not willing to participate in this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome variables. - Primary Caesarean for fetal distress,	1 year

Secondary Outcome Measures

Name	Time	Method
Induction delivery interval	Maternal and perinatal outcome

Trial Locations

Locations (1): malankara orthodox syrian church medical college,kolenchery
🇮🇳
Ernakulam, KERALA, India
malankara orthodox syrian church medical college,kolenchery
🇮🇳Ernakulam, KERALA, India
Dhanya paul
Principal investigator
9495510265
dhanyapaulmary@gmail.com