A study comparing a drug causing labor pains when given orally vs vaginally in pregnant women

Not yet recruiting

Conditions: Encounter for full-term uncomplicated delivery,

Registration Number: CTRI/2021/01/030348

Lead Sponsor: DRRPGMC Kangra

Brief Summary: Induction of labor (IOL) implies stimulation of contractions before the spontaneous onset of labor, with or without ruptured membranes. It is an intervention designed for iatrogenic ripening of cervix and to initiate uterine contractions leading to progressive dilatation and effacement of cervix resulting into birth of the newborn. It is indicated only when the risks of continuing pregnancy outweigh the benefits to the mother and the fetus.

Methods of IOL presently in use include various mechanical, pharmacological or a combination of mechanical and pharmacological.

Mechanical methods include use of various agents such as transcervical folleys catheter(TCFC) inflated with various amounts of fluid, laminaria tents, synthetic osmotic dilators etc. TCFC is cheap, readily available and easy to use and moreover less painful alternative which affects changes on various components of the bishop score and does not cause overstimulation of the uterus and does not increase the risk of rupture or intrauterine infection and does not adversely affect the fetus and newborn. However its potential side effects include premature rupture of membranes, chorioamnionitis, bleeding, displacement of presenting part and futire risk of preterm bith.

Pharmacological methods of IOL include agents such as oxytocin, prostaglandins, relaxin, nitic oxide donors such as isosorbide mononitrate, mifepristone etc out of which prostaglandins are the most widely used agents which include various sub classes such as PGE1 ie. Misoprostol and PGE2 known commonly as dinoprostone which is being used as gel and tablet, has the advantage of being used intracervical or vaginally but is expensive and needs refrigeration. Misoprostol originally used as gastroprotective agent , has advantage of being cheap, stable at room temperature and easy to be administered by various routes i.e. vaginal, oral, sublingual or rectal where the former two routes of administration are most commonly used .

Absorption by oral route is more rapid than vaginally administered misoprostol reaching peak serum concentrations within 30 min compared to one hour with vaginal route. Oral misoprostol is eliminated rapidly (2â€“3 h) than vaginal (>=4 h). In 2014, a Cochrane review on the use of orally administered misoprostol for IOL suggested that vaginal misoprostol was less effective than oral misoprostol at achieving vaginal birth, with an increased risk of uterine tachysystole and CS with vaginal misoprostol

Nowadays, a combination approach using pharmacological and mechanical methods is followed for IOL. Whereas misoprostol is more effective in improving the scores of cervical length and consistency, TCFC is better at improving the cervical dilatation score at pre-induction cervical ripening; thus, both improve different parameters.Both oral and vaginal routes of misoprostol for IOL have its merits and demerits and its efficacy and safety as an adjunct with TCFC has not been widely studied. IOL may lead to longer lengths of stay, increased hospital costs and increased newborn and maternal morbidities. In order to mitigate these risks, it is important to choose methods of IOL which are safe and efficacious in achieving a vaginal delivery.

Hence, we plan to compare TCFC with oral vs vaginal misoprostol as an adjunct for IOL in pregnant women at term.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 200

Inclusion Criteria

1.fetal malpresentations 2.rupture of membranes/ pre-existing chorioamnionitis 3.previous uterine surgery( CS/ hysterotomy/ myomectomy/metroplasty) 4.multifetal gestation 5.antepartum bleeding 6.intrauterine fetal demise 7.Anencephaly 8.allergy to latex.
9.All contraindications to vaginal delivery (eg carcinoma cervix, structural pelvic abnormalities eg rachitic pelvis, Cephalopelvic disproportion.) 10.A previous attempted IOL during current pregnancy.
11.Placenta or vasa previa or cord presentation.
12.Active genital herpes.
13.Contraindications to prostaglandins (eg.
Asthma, acute PID, hypersensitivity) 14.Any co-morbid surgical illness (eg.
Pyelonephritis, etc) 15.Non reassuring fetal heart rate status.

Exclusion Criteria

1.fetal malpresentations 2.rupture of membranes/ pre-existing chorioamnionitis 3.previous uterine surgery( CS/ hysterotomy/ myomectomy/metroplasty) 4.multifetal gestation 5.antepartum bleeding 6.intrauterine fetal demise 7.Anencephaly 8.allergy to latex.
9.All contraindications to vaginal delivery (eg carcinoma cervix, structural pelvic abnormalities eg rachitic pelvis, Cephalopelvic disproportion.) 10.A previous attempted IOL during current pregnancy.
11.Placenta or vasa previa or cord presentation.
12.Active genital herpes.
13.Contraindications to prostaglandins (eg.
Asthma, acute PID, hypersensitivity) 14.Any co-morbid surgical illness (eg.
Pyelonephritis, etc) 15.Non reassuring fetal heart rate status.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure induction-delivery interval.	At the time of delivery (O HOURS- SINGLE OBSERVATION AT BASELINE)

Secondary Outcome Measures

Name	Time	Method
Duration from IOL to active phase of labor ( defined as â‰¥ three or more painful contractions in 10 minutes, 80% or greater effacement or cervical dilation of more than 3 cm).	As mentioned above.
delivery rates	Within 12 and 24 hours of induction of labor
Proportion of women undergoing CS in both groups.	after delivery of the woman.
Incidence of failure of Induction.	4 hours post 5th dose of misoprostol.
â€¢Incidence of hyperstimulation in two groups ( hyperstimulation defined as a single contraction lasting for more than 2 minutes or 5 or more contractions in 10 minutes with fetal heart rate changes)	not applicable
Meconium stained liquor.	not applicable
Incidence of chorioamnionitis ( defined as maternal temperature of more than 38 Celsius during and after labor).	during and post 48 hours of delivery
Neonatal outcomes including: Apgar score (1 min & 5 min),Need of phototherapy (if required; duration),Intensive care admission (if required)

Trial Locations

Locations (1): Dr.RPGMC Tanda At Kangra
🇮🇳
Kangra, HIMACHAL PRADESH, India
Dr.RPGMC Tanda At Kangra
🇮🇳Kangra, HIMACHAL PRADESH, India
Dr Kanan Rambani
Principal investigator
7986488185
Kananrambani@gmail.com