A clinical trial to study the effect of two drugs for induction of labor: low dose misoprostol and dinoprostone

A RANDOMISED CONTROLLED TRIAL COMPARING LOW DOSE VAGINAL MISOPROSTOL AND DINOPROSTONE GEL FOR LABOUR INDUCTION

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000160

Enrollment

320

Registered

2008-09-22

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: 25 micrograms of misoprostol or 0.5 mg of dinoprostone gel: 25 micrograms of misoprostol (quartering 100 &micro

g tablets) or 0.5 mg of dinoprostone gel every 6 hourly to a maximum of 3 doses in 24 hours. Control Intervention1: dinoprostone gel: 0.5 mg of dinoprostone gel every 6 hourly to a maximum of 3 doses

g tablets) every 6 hours to a maximum of 3 doses in 24 hours

Eligibility

Inclusion criteria

Inclusion criteria: Women requiring induction of labor due to medical reasons with singleton pregnancy and vertex presentation with no contraindication for vaginal delivery will be included in the study. The following inclusion criteria 1.Cervical score <5, 2.Amniotic fluid index > 5 3. Reactive fetal heart rate pattern 4.Past dated pregnancies with period of gestation 40 weeks or more

Exclusion criteria

Exclusion criteria: 1) parity >3 2) prior uterine scars ( previous caesarian section and myomectomy) 3) multiple pregnancy 4) estimated fetal weight >4500 or <2000g 5) abnormal fetal heart rate (FHR) tracings on non stress test 6) placenta previa 7) hypersensitivity to prostaglandins 8) renal, hepatic or cardiovascular disease 9) severe asthma

Design outcomes

Primary

Measure	Time frame
Induction-to-vaginal delivery intervalTimepoint: within 24 hours	—

Secondary

Measure	Time frame
1. requirements for oxytocin 2. mode of delivery 3. number of women delivering <24 hours 4. incidence of uterine contraction abnormalities 5. incidence of abnormal cardiotocograph 6. Apgar scores 7. meconium staining liquor 8. admission to neonatal intensive care units 9. Maternal side effects 10. Maternal satisfaction Timepoint: parameters will be recorded after delivery. maternal satisfaction will be recorded after 24 hours of delivery	—

Measure

Time frame

1. requirements for oxytocin 2. mode of delivery 3. number of women delivering <24 hours 4. incidence of uterine contraction abnormalities 5. incidence of abnormal cardiotocograph 6. Apgar scores 7. meconium staining liquor 8. admission to neonatal intensive care units 9. Maternal side effects 10. Maternal satisfaction Timepoint: parameters will be recorded after delivery. maternal satisfaction will be recorded after 24 hours of delivery

—

Countries

India

Contacts

Public ContactDr A P Manjunath

Associate Professor of Obstetrics & Gynecology, Kasturba Medical College, Manipal

manjunath.ap@manipal.edu0820 2922211

Outcome results