Effectiveness and safety of oral misoprostol Vs intravaginal PGE2 (Dinoprostone) for pre-induction cervical ripening in women with uncomplicated, singleton, post dated pregnancies: a randomized controlled study.

Oral misoprostol Vs intravaginal PGE2 (Dinoprostone) for pre-induction cervical ripening in women with uncomplicated, singleton, post dated pregnancies: a randomized controlled study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2021/022

Enrollment

Unknown

Registered

2021-07-31

Start date

2021-08-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Induction of labour

Interventions

Study setting: Study will be conducted in Obstetric ward, Teaching Hospital Anuradhapura. Method of Randomization: Pregnant women who are included in the study will be randomized into interventional(m

Eligibility

Inclusion criteria

Inclusion criteria: • Nulliparous pregnant women • In a singleton pregnancy • At 40 weeks and 5 days of gestation • Fetus in cephalic presentation with intact membranes • Modified bishop score(MBS) of < 5 • Not having any contraindications for vaginal delivery

Exclusion criteria

Exclusion criteria: • past caesarian delivery • history of myomectomy • hypersensitivity to misoprostol • pregnancy induced hypertension • gestational diabetes mellitus • multiple pregnancies

Design outcomes

Primary

Measure	Time frame
To compare the number of women who establish spontaneous onset of labor (SOL) [Period of gestation - 40 weeks+6 days of gestation following the intervention at 40 weeks +5 days of gestation] To compare the number of women who do not establish SOL ,but become favorable for induction of labor(IOL) with modified Bishops Score (MBS) ?7. [Period of gestation 40 weeks+6 days of gestation following the intervention at 40 weeks +5 days of gestation] To compare the number of women who do not establish SOL and who are not favorable for IOL following 24 hours of the intervention. [Period of gestation 40 weeks+6 days of gestation following the intervention at 40 weeks +5 days of gestation] To compare the intervention to delivery time in those who establishes SOL following interventions. [Period of gestation 40 weeks+6 days ]	—

Measure

Time frame

To compare the number of women who establish spontaneous onset of labor (SOL) [Period of gestation - 40 weeks+6 days of gestation following the intervention at 40 weeks +5 days of gestation] To compare the number of women who do not establish SOL ,but become favorable for induction of labor(IOL) with modified Bishops Score (MBS) ?7. [Period of gestation 40 weeks+6 days of gestation following the intervention at 40 weeks +5 days of gestation] To compare the number of women who do not establish SOL and who are not favorable for IOL following 24 hours of the intervention. [Period of gestation 40 weeks+6 days of gestation following the intervention at 40 weeks +5 days of gestation] To compare the intervention to delivery time in those who establishes SOL following interventions. [Period of gestation 40 weeks+6 days ]

—

Secondary

Measure	Time frame
To compare the number of women who needed emergency cesarean delivery following intervention and after going into vaginal delivery within 48 hours. [Period of gestation 40 weeks+ 7 days ] To compare the number of women who had pathological CTG required emergency cesarean delivery following intervention and after starting vaginal delivery after intervention. [ Period of gestation 40 weeks+ 7 days ] To compare the maternal morbidity, number of patients with: • uterine hyperstimulation occurring within first 24 hours after intervention • requiring post partum blood transfusion due to post partum haemorrhage • with uterine rupture following intervention and during labour. [ Period of gestation 40 weeks+ 6 days ] To compare the fetal and neonatal outcome and morbidity. • CTG considered to be Suspicious or Pathological as per FIGO Guidelines within first 24 hours following intervention • Presence of meconium stained liquor at the time of doing artificial rupture of membranes and delivery or detected during labour by vaginal examination • APGAR scores <5 at 1 minute after delivery • Admission to the PBU/NICU within first 24 hours after delivery and its reason [ Period of gestation 40 weeks+ 6 days ]	—

Measure

Time frame

To compare the number of women who needed emergency cesarean delivery following intervention and after going into vaginal delivery within 48 hours. [Period of gestation 40 weeks+ 7 days ] To compare the number of women who had pathological CTG required emergency cesarean delivery following intervention and after starting vaginal delivery after intervention. [ Period of gestation 40 weeks+ 7 days ] To compare the maternal morbidity, number of patients with: • uterine hyperstimulation occurring within first 24 hours after intervention • requiring post partum blood transfusion due to post partum haemorrhage • with uterine rupture following intervention and during labour. [ Period of gestation 40 weeks+ 6 days ] To compare the fetal and neonatal outcome and morbidity. • CTG considered to be Suspicious or Pathological as per FIGO Guidelines within first 24 hours following intervention • Presence of meconium stained liquor at the time of doing artificial rupture of membranes and delivery or detected during labour by vaginal examination • APGAR scores <5 at 1 minute after delivery • Admission to the PBU/NICU within first 24 hours after delivery and its reason [ Period of gestation 40 weeks+ 6 days ]

—

Countries

Sri Lanka

Contacts

Public ContactDr.Y.N.Godakanda

Senior Registrar in Gynaecology and Obstertricss

yasiru05@gmail.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026