EVALUATION OF ISOSORBIDE MONONITRATE FOR CERVICAL RIPENING PRIOR TO INDUCTION OF LABOUR FOR POSTDATED PREGNANCY IN OUTPATIENT SETTING

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/091/000121

Enrollment

200

Registered

2011-02-03

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

None listed

Interventions

Intervention1: isosorbide mononitrate: 40mg 2 doses 12 hrs apart Control Intervention1: pyridoxine: 40mg 2 doses 12hrs apart

Eligibility

Inclusion criteria

Inclusion criteria: ? Age 18-35 years ? > 40 completed weeks of gestation ? Singleton fetus ? Cephalic presentation ? Absence of uterine contractions ? Unfavorable cervix (Bishop<6) ? Intact membranes ? Reactive NST

Exclusion criteria

Exclusion criteria: . Fetal malpresentation ? Antepartum hemorrhage ? Previous uterine incision ? Ruptured membranes ? Contraindication to receive IMN or Prostaglandins (allergy, bronchial asthma, hypotension, palpitation) ? Pregnancy with high risk factors (Preeclampsia, Oligohydramnios, IUGR, medical complications such as diabetes mellitus, heart disease and hypertension.

Design outcomes

Primary

Measure	Time frame
1. Bishop score: Pre & Post treatment with the drug 2. Time elapsed from hospital admission (for patient induction / admission in labor) to delivery either vaginally or cesarean section. 3. Adverse maternal outcome: Uterine hyperstimulation, tachysystole, tachycardia, hypotension, headache, palpitations, fever & shivering. 4. Adverse fetal outcome: meconium stained liquor, Apgar at 1 & 5 minutes, neonatal admission. Timepoint: nil	—

Measure

Time frame

1. Bishop score: Pre & Post treatment with the drug 2. Time elapsed from hospital admission (for patient induction / admission in labor) to delivery either vaginally or cesarean section. 3. Adverse maternal outcome: Uterine hyperstimulation, tachysystole, tachycardia, hypotension, headache, palpitations, fever & shivering. 4. Adverse fetal outcome: meconium stained liquor, Apgar at 1 & 5 minutes, neonatal admission. Timepoint: nil

—

Secondary

Measure	Time frame
1. Unscheduled admissions for reasons other than labor commencing. 2. Requirement of additional inpatient cervical ripening agent. 3. Subsequent need for oxytocin. 4. 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). 5. Complications: Postpartum hemorrhage. Timepoint: nil	—

Measure

Time frame

1. Unscheduled admissions for reasons other than labor commencing. 2. Requirement of additional inpatient cervical ripening agent. 3. Subsequent need for oxytocin. 4. 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). 5. Complications: Postpartum hemorrhage. Timepoint: nil

—

Countries

India

Contacts

Public ContactDr. Achla Batra

Senior Specialist

achla_batra@yahoo.com9811105560

Outcome results