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Effect of sublingual Misoprostol versus vaginal Misoprostol in labor induction success.

Comparison of Sublingual and vaginal Misoprostol for labor induction in primiparous women

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT138903121096N3
Enrollment
126
Registered
2010-06-02
Start date
2010-07-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

labour induction. Precipitate labour

Interventions

Intervention 1: Prescription of 25 microgram of sublingual Misoprostol plus vaginal placebo every four hours up to four times. Intervention 2: Prescription of 50 microgram of vaginal Misoprostol plu
Treatment - Drugs
Prescription of 25 microgram of sublingual Misoprostol plus vaginal placebo every four hours up to four times.
Prescription of 50 microgram of vaginal Misoprostol plus sublingual placebo every four hours up to four times.

Sponsors

Vice chancellor for research -Guilan university of medical sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: a) single pregnancy (between 36 to 42 weeks), b) vertex presentation, c) intact fetal membrane, d) bishop score equal or less than four e) absence of uterus spontaneous contractions f) fetal weight less than 4000gr j) normal fetal heart rate h) cephalopelvic proportion Exclusion criteria: a) sensitivity to PGs b) previous history of cesarean c) uterus wall scar d) preeclampsia or blood pressure more than 140/90 mmhg e) PROM f) vaginal bleeding

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Time interval from labour induction to delivery. Timepoint: After delivery. Method of measurement: Time recording of induction beginning and delivery in Questionnaire.;Delivery type frequency. Timepoint: After delivery. Method of measurement: patient medical document.;Dose amount. Timepoint: Four hours after last prescription of Misoprostol up to delivery time. Method of measurement: Patient medical document.

Secondary

MeasureTime frame
Vaginal delivery frequency during first 12 hours. Timepoint: During 12 hours from induction beginning. Method of measurement: Patient medical document.;Vaginal delivery frequency during first 12 to 24 hours. Timepoint: During 12 to 24 hours from induction beginning. Method of measurement: Patient medical document.;Tachysystole incidence rate. Timepoint: Every 4 hours until entering in active phase. Method of measurement: Fetal heart monitoring device and recording of uterus contractions.;Hyper stimulation incidence rate. Timepoint: Every 4 hours until entering in active phase. Method of measurement: Fetal heart monitoring device and recording of uterus contractions.;Cesarean rate due to FHR disorder. Timepoint: After cesarean. Method of measurement: patient medical document.;Cesarean section rate due to delivery failure. Timepoint: After cesarean section. Method of measurement: Patient medical document.;Apgar score below 7 rate. Timepoint: After delivery. Method of measurement: Patient medical document.;Meconium discharge rate. Timepoint: By presenting 3cm or more dilatation after rupture of membrance. Method of measurement: Clinical examination or patient medical document.;NICU admission rate. Timepoint: After delivery. Method of measurement: Patient medical document.;Bishop score alteration average after 4 hours. Timepoint: After 4 hours from beginning of induction. Method of measurement: Vaginal examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Seyede Hajar Sharami

Guilan university of medical sciences

Sharami@gums.ac.ir+98 911 131 3242

Outcome results

None listed

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