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Extra-Amniotic Normal Saline Infusion plus Hydrocortisone versus Prostaglandin E2 Suppository for Pregnancy Termination

Comparison of Extra-Amniotic Normal Saline Infusion plus Hydrocortisone versus Prostaglandin E2 Suppository for Pregnancy Termination

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201109107520N1
Enrollment
50
Registered
2011-12-29
Start date
2004-04-20
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

Induction of labor, termination of pregnancy. Medical abortion: Incl: termination of pregnancy: legal

Interventions

Intervention 1: Prostaglandin group (25 patients) was received two doses of prostaglandin E2 intra vaginal suppository (Dinoprostone) 3mg every 4 hour. In both groups, 6 hours after the last dose of p
Treatment - Drugs
Prostaglandin group (25 patients) was received two doses of prostaglandin E2 intra vaginal suppository (Dinoprostone) 3mg every 4 hour. In both groups, 6 hours after the last dose of prostaglandin and
In EASHI group (25 patients), under sterile conditions, a coworker inserted a No. 14 Foley catheter through the cervical canal and balloon was filled with 20 ml water and fixed. Then 360 ml sterile No

Sponsors

Vice Chancellor for research, Kermanshah University of Medical Sciences (KUMS)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria :Multiparus ?reater than or equal to 4; Bishop Score less than or equal to 2; Gestational age 14-28 weeks; Amniotic sac intact; Fetal indication of Pregnancy Termination. Exclusion criteria : Placenta Previa; Uterus Anomalies; Rupture of Membrane; History of Hypertension; Fever; Cardiac Disease; Previous Scar on the Uterus; Drug Sensitivity (Prostaglandin E2 and Hydrocortisone); contraction of uterus.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mean time from initiation of induction till expultion of conception. Timepoint: Hour. Method of measurement: Excretion products of pregnancy.

Secondary

MeasureTime frame
The need to curettage. Timepoint: 24 hours after fetus expultion. Method of measurement: Residual of conception based on ultrasonography.;Uterus hyperton. Timepoint: Hour. Method of measurement: The Uterine contractions of more than two minutes.;Placenta retention. Timepoint: Every 20 minutes. Method of measurement: Retention of placenta up to half an hour after expulsion of fetus.;Success rate of pregnancy termination. Timepoint: hour. Method of measurement: Expultion of pregnancy conception.;Diarrhea. Timepoint: Every 4 hours. Method of measurement: The passage of three or more loose or watery stools a day.;Fever. Timepoint: Every 4 hours. Method of measurement: Temperature above 38 ° C sublingual.;Hypertension. Timepoint: Every 4 hours. Method of measurement: Blood pressure greater than or equal to 140/90 mm Hg.;Hypotension. Timepoint: Every 4 hours. Method of measurement: Blood pressure less than 90/70 mm Hg.;Tachy systole. Timepoint: Hour. Method of measurement: More than 6 uterine contractions in ten minutes.;Nausea, vomiting. Timepoint: Every 4 hours. Method of measurement: Based on patient complaints and symptoms of disease by observing investigator.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Farahnaz Keshavarzi

Kermanshah University of Medical Sciences (KUMS)

fnkeshavarzi@kums.ac.ir , fnkeshavarzi@yahoo.com+98 83 1724 2893

Outcome results

None listed

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