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

A Randomised Controlled Trial Comparing Transcervical Foleys Catheter With Oral V/S Vaginal Misoprostol In Pregnant Women At Term For Induction Of Labor

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030348
Enrollment
200
Registered
2021-01-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: To Compare Oral Vs Vaginal Misoprostol Along With transcervical foleys catheter For induction of labor In Pregnant Women: All the women participating in the study will be inserted with

Sponsors

DRRPGMC Kangra
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To measure induction-delivery interval.Timepoint: At the time of delivery (O HOURS- SINGLE OBSERVATION AT BASELINE)

Secondary

MeasureTime frame
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)Timepoint: not applicable;delivery ratesTimepoint: Within 12 and 24 hours of induction of labor;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).Timepoint: As mentioned above.;Incidence of chorioamnionitis ( defined as maternal temperature of more than 38 Celsius during and after labor).Timepoint: during and post 48 hours of delivery;Incidence of failure of Induction.Timepoint: 4 hours post 5th dose of misoprostol.;Meconium stained liquor.Timepoint: not applicable;Neonatal outcomes including: Apgar score (1 min & 5 min),Need of phototherapy (if required; duration),Intensive care admission (if required) Timepoint: After delivery;Proportion of women undergoing CS in both groups.Timepoint: after delivery of the woman.

Countries

India

Contacts

Public ContactDr CD Sharma

DR.RPGMC, KANGRA AT TANDA HIMACHAL PRADESH

Kananrambani@gmail.com7986488185

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026