RANDOMIZED COMPARISON OF 2 DRUGS FOR CERVICAL RIPENING IN TERM PREGNANCY

RANDOMIZED COMPARISON OF ISOSORBIDE MONONITRATE AND PGE2 GEL FOR PRE- INDUCTION CERVICAL RIPENING IN TERM PREGNANCY

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/07/003808

Enrollment

500

Registered

2013-07-15

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: null- PRE- INDUCTION CERVICAL RIPENING IN TERM PREGNANCY

Interventions

Intervention1: Isosorbide mononitrate: 40 mg 2 doses 12 hrs apart Control Intervention1: PGE2: 0.5 mg 2 doses 6hrs apart

Eligibility

Inclusion criteria

Inclusion criteria: 37 completed weeks of gestation, Singleton fetus, Cephalic presentation, Absence of uterine contractions, Unfavorable cervix (Bishop

Exclusion criteria

Exclusion criteria: Fetal malpresentation, Antepartum hemorrhage, Previous uterine incision, Ruptured membranes, Contraindication to receive IMN or Prostaglandins(allergy, bronchial asthma, hypotension, palpitation), Severe anemia, Heart disease

Design outcomes

Primary

Measure	Time frame
1.Bishop score: Pre & Post treatment with the drug 2.Labor characteristics &induction- delivery interval 3.Adverse maternal outcome: Uterine hyperstimulation, tachysystole, tachycardia, hypotension, headache, palpitations, fever, shivering & gastrointestinal symptoms. 4.Adverse fetal outcome: meconium stained liquor, Apgar at 1 & 5 minutes, nursery admission. Timepoint: nil	—

Secondary

Measure	Time frame
1.Subsequent need for oxytocin. 2.Operative delivery rates (Cesarean section done for obstetric indications including failed induction, arrest of dilation, arrest of descent, and persistent non reassuring fetal heart rate pattern after resuscitation). 3.Complications: Postpartum hemorrhage. Timepoint: nil	—

Countries

India

Contacts

Public ContactDr Kavita Agarwal

Dr. BATRA, Deptt. obs. & gynae, Safdarjung Hospital, CGHS

drku93@gmail.com9990167888

Outcome results

None listed

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