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Induction of labor with 3 different methods.

A comparison between induction of labor with 3 methods of titrated oral misoprostol, constant dose of oral misoprostol and folly catheter with extra amniotic saline infusion (EASI), in women with unfavorable cervix.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201702282624N22
Enrollment
116
Registered
2017-04-03
Start date
2014-04-05
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

Condition 1: Delivery. Condition 2: Outcome of delivery. Pregnancy, childbirth and the puerperium Outcome of delivery

Interventions

Intervention 1: In oral titrared misoprostol group: 200µg misoprostol tablet will be solved in 200 milliliter of water (this solution is stable in the room temperature and contains 1µg misoprostol in
Treatment - Drugs
In oral titrared misoprostol group: 200µg misoprostol tablet will be solved in 200 milliliter of water (this solution is stable in the room temperature and contains 1µg misoprostol in 1mlit of soluti
In oral misoprostol group, 50µg misoprostol will be administered and women will be followed up to 4 hours. FHR and uterine contractions will be checked hourly. In the cases of not having suitable con
In the EASI group, folly catheter of number 18 was introduced through cervical canal and was filled with 30mlit distilled water and was fixed above the internal cervical OS, and was connected to norma

Sponsors

Vice chancellor for research ,Iran University of Medical Sciences.
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria : maternal age between 18-40 years old; gestational age of more than 37 weeks ; singleton, cephalic presentation, intact membrane and Bishop Score of less than 6. Exclusion criteria : any sign of fetal distress; placenta previa and any vaginal bleeding of more than bloody show; history of any surgery on uterus including cesarean section; known uterine anomaly; intra uterine fetal death, and known hypersensitivity to misoprostol.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Delivery during the first 24 hours after intervention. Timepoint: 24 hours. Method of measurement: Data sheets.

Secondary

MeasureTime frame
Duration of the stages of labor. Timepoint: 1 hour. Method of measurement: Data sheets.;The adverse effects in mothers. Timepoint: each hour. Method of measurement: Data sheets.;The adverse effects in neonates. Timepoint: After birth up to discharge. Method of measurement: Data sheets.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Kashanian

Iran University of Medical Sciences

maryamkashanian@yahoo.com+98 21 5563 3244

Outcome results

None listed

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