A clinical trial to compare the concurrent use of vaginal misoprostol and transcervical foley catheter inflated with 60 ml vs 80 mlin nulliparous women at term for induction of labor

Completed

Conditions: Encounter for full-term uncomplicated delivery,

Registration Number: CTRI/2021/09/036921

Lead Sponsor: Dr RPGMC Kangra

Brief Summary: Induction of labor (IOL) implies stimulation of uterine contractions before the spontaneous onset of labor, with or without ruptured membranes.1 It is an intervention designed for iatrogenic ripening of cervix and to initiate uterine contractions leading to progressive dilatation and effacement of cervix resulting in birth of the newborn. The goal of IOL is to achieve a successful vaginal delivery with minimal maternal and fetal complications. Cervical ripening is an important factor for a successful IOL. Unripe cervix with a lower Bishop score is associated with an increased risk of failure of IOL, while a favorable cervix signiï¬cantly predicts a timely delivery. There are two main methods of cervical ripening. One is mechanical, including (1) the introduction of a catheter through the cervix into the extra-amniotic space with balloon insuï¬„ation; (2) introduction of laminaria tents, or their synthetic equivalent, into the cervical canal; (3) use of a catheter to inject ï¬‚uid into the extra-amniotic space. Transcervical foleyâ€™s catheter (TCFC) is cheap, easy to use, readily available, relatively painless and reversible method for IOL. The other method is pharmacological. Pharmacological methods include many agents, such as prostaglandins (PG) such as misoprostol i.e. PGE1 and dinoprostone i.e. PGE2 , progesterone receptor antagonists (mifepristone), oxytocin, and nitric oxide (NO) donors, but the most commonly used are prostaglandins and oxytocin. although the best agent and method for IOL remains uncertain, it is biologically plausible that a combination of a mechanical device (TCFC) and mechanical agent (misoprostol) may have a synergistic effect, resulting in a greater degree of cervical ripening and shorter induction to delivery time with concomitant reduction of side effects of each.In an attempt to raise the bishop score at a faster rate and decrease the time to delivery, TCFC are often overinflated or TCFC that accept larger volumes are used.13 The likelihood of vaginal delivery is correlated with a higher Bishop score at the time of induction, hence it is postulated that a higher volume TCFC used for cervical ripening will be associated with a higher bishop score which will further lead to higher rate of vaginal delivery.14

Hence, we plan to compare variable volumes of inflation of TCFC as an adjunct for IOL in pregnant nulliparous women at term.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 200

Inclusion Criteria

Single live intrauterine fetus with cephalic presentation period of gestationgreater than equal to 40 weeks.

Exclusion Criteria

women in spontaneous labor fetal malpresentation rupture of membranes previous uterine surgery multifetal gestation antepartum haemorrhage all contraindications to vaginal delivery(rachitic elvis, carcinoma cervix,CPD) Intruterine fetal death allergy to latex placenta vasa previa or cord presentation active genital herpes contraindications to prostaglandins any co morbid surgical illness Non reassuring fetal heart rate any previous attempt of IOLin present pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Induction delivery interval (defined as time from TCFC insertion to delivery of fetus)	Induction delivery interval (defined as time from TCFC insertion to delivery of fetus)

Secondary Outcome Measures

Name	Time	Method
duration from IOL to active labour	as mentioned above
duration of labor(defined as time from start of active phase until delivery of fetus	as mentioned above
proportion of women delivered vaginally	withi 12 to 24 hours of induction of labor
Proportion women undergoing CS
proportion of women with failure of IOL	if there is no contraction or Bishop score less than 6 even after 5 doses of misoprostol
Time period between insertion of TCFC and spontaneous expulsion of TCFC	maximum 12 hours after insrtion of TCFC after which it shall be removed
incidence of chorioamniontis
meconium stained liquor	not applicable
incidence of hyperstimulation	not applicable
neonatal outcomes(apgar score at 1 min and 5 min)	neonatal intensive care admission

Trial Locations

Locations (1): Antenatal ward Department of obstetrics and gynecology
🇮🇳
Kangra, HIMACHAL PRADESH, India
Antenatal ward Department of obstetrics and gynecology
🇮🇳Kangra, HIMACHAL PRADESH, India
sakshi jaryal
Principal investigator
8894219268
sakshijaryal@gmail.com