Comparing drug versus drug with catheter in low risk first time pregnant mothers for labor induction

Completed

Conditions: Pregnant women who are planned for induction of labor

Registration Number: CTRI/2018/08/015553

Lead Sponsor: CMC vellore

Brief Summary: Induction of labour is the stimulation of uterine contractions before the spontaneous

onset of labour, in the presence or absence of membranes (1).

Induction of labour is indicated in cases where continuation of pregnancy poses more

risk than benefit to the mother or/and fetus. Some examples of these situations are,

rupture of membranes before the start of uterine contractions, oligohydramnios,

gestational hypertension, intrauterine growth restriction, maternal indications such as

diabetes mellitus/ chronic hypertension (2). Easy availability of ripening agents, and

patient request also play an important role in increasing rates of induction of labour

(3). Electively inducing labour for convenience to the obstetricians schedule has also

been recognized as a major contributing factor (4).

**Induction of labour at term**: Continuation of pregnancy beyond 42 weeks is

associated with complications to the mother and the fetus. A Cochrane review studied

22 trials that induced labour between 37 and 42 weeks of gestation, compared to

waiting for spontaneous labour (5). It was found that earlier induction resulted in

fewer perinatal deaths, less meconium aspiration and fewer caesareans than the policy

of waiting. A systematic review by Caughey et al which included 11 randomised

control trials suggested that elective induction of labour after 41 weeks resulted in a

decreased risk for caesarean delivery and meconium stained amniotic fluid (6).

**Prevalence of Induction of Labour**: Induction rates seem to have increased in the

last decade. A study done in the US showed that the rate of induction of labour has

increased nationwide from 9.5% to 19.4% between the years 1990 and 1998 (3).

Increased rates of medically indicated inductions did not contribute to this rise as

much as marginally indicated, or elective inductions. These contribute to at least half

of all inductions, and induction of labour in nulliparas with an unfavourable cervix

results in rising rates of caesarean sections (7).

A national survey was done in the USA by Childhood Connection to ascertain the

experiences of women during pregnancy and labour (8) . 2400 women completed a

detailed online questionnaire. 41% of these women underwent induction of labour.

The most common rationale given to these mothers for inducing labour was that the

baby was overdue (18%), and a maternal health problem that required a quick delivery

(18%).

In Christian Medical College, Vellore, incidence of induction of labour whenever

indicated, is about 15- 20%. The rate of primary LSCS is about 18-24%, failed

induction accounting for 6-10% of cases

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 608

Inclusion Criteria

1 Primigravida 2 37 completed weeks to 40+6 weeks of gestation 3 Low risk pregnancy 4 Singleton, cephalic presentation, live fetes 5 Intact membranes 6 Bishops Score <6 (not in labour) â€¢Reactuve preinduction CTG.

Exclusion Criteria

1 Multigravida 2 Bishops Score >6 3 High Risk Pregnancy 4 Rupture of membranes 5 Maternal fever 6 Non vertex presentation 7 Non reassuring CTG 8 Reinduction (previously unsuccessful induction of labour) 9 Allergy to Misoprostol/ latex 10 Previous LSCS/myomectomy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Induction to delivery interval	once

Secondary Outcome Measures

Name	Time	Method
Rate of vaginal delivery	Rate of primary LSCS

Trial Locations

Locations (1): Christian Medical College
🇮🇳
Vellore, TAMIL NADU, India
Christian Medical College
🇮🇳Vellore, TAMIL NADU, India
Dr Jessie Lionel
Principal investigator
9566804173
jessielionel@cmcvellore.ac.in