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Evaluation of the effect of vaginal Progesterone in preventing preterm labor

Evaluation of the effect of vaginal Progesterone in preventing preterm labor

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138706051096N1
Enrollment
260
Registered
2009-02-20
Start date
2009-01-22
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

prevention of preterm labor. Preterm labour

Interventions

Intervention 1: Intervention group: Progesterone vaginal supp (200 mg)
after two hours, the subject was examined for cessation of labor pain. If no contraction was detected she was given a vaginal supp per day. Intervention 2: Control group: Placebo vaginal supp (200 mg)
after two hours, the subject was examined for cessation of labor pain. If no contraction was detected she was given a vaginal supp per day.
Intervention group: Progesterone vaginal supp (200 mg)
Control group: Placebo vaginal supp (200 mg)

Sponsors

Vice Chancellor for research-Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Pregnant women were eligible to enter the trial if 1) they were between 26-36 weeks of gestation based on their LMP or sonography before 16 weeks of gestation. 2) Confirmation of premature delivery with a)uterine contractions more than 30 seconds and three or more contractions per 30 minutes established by tochodynamometer b) cervical dilatation of 0-2 cm in nulliparous and 1 -2 cm in multiparous and cervical effacement greater than 50% 3) intact membrane. Exclusion criteria included: 1) unwillingness or inability to comply with study procedures before 36 weeks of gestation 2) lack of useful sufficient data 3) preeclampsia requiring termination of pregnancy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Prevention of preterm labour( before 37 weeks). Timepoint: 2 hours after insertion of suppository, then weekly visit. Method of measurement: control of uterine contraction.;Prevention of preterm labor (before 34 weeks). Timepoint: every two weeks. Method of measurement: Patient visits, uterine contraction determination.

Secondary

MeasureTime frame
Delay of delivery. Timepoint: post partum. Method of measurement: documented data.;Duration of hospitalization. Timepoint: post partum (weekly). Method of measurement: documented data.;Mean of frequancy,intensity and duration of contractions. Timepoint: 48 hours after initiation of therapy. Method of measurement: detected by Tochodynamometer.;Delay of delivery. Timepoint: postpartum. Method of measurement: documented data.;Delay for a week of delivery. Timepoint: after delivery. Method of measurement: documented data.;Low birth weight. Timepoint: after delivery. Method of measurement: documented data.;APGAR score below 7. Timepoint: after delivery. Method of measurement: documented data.;NICU admission. Timepoint: after delivery. Method of measurement: documented data.;Perinatal Mortality. Timepoint: after delivery. Method of measurement: documented data.;Fetal death. Timepoint: after delivery. Method of measurement: documented data.;Neonatal distress. Timepoint: after delivery. Method of measurement: documented data.;Postpartum Retinopathy. Timepoint: after delivery. Method of measurement: documented data.;Necrotizing entrocolitis. Timepoint: after delivery. Method of measurement: documented data.;Neonatal sepsis. Timepoint: after delivery. Method of measurement: documented data.;Intraventicular hemorrhage. Timepoint: after delivery. Method of measurement: documented data.;Side effects of progesteron. Timepoint: every two weeks. Method of measurement: interview.;Premature rupture of membranes. Timepoint: during delivery. Method of measurement: documented data.;Chorioamnionitis. Timepoint: after delivery. Method of measurement: documented data.;Severe hemorrhage (blood transfusion). Timepoint: after delivery. Method of measurement: documented data.;Days of hospitalization. Timepoint: after delivery. Method of measurement: documented data.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Seyede Hajar Sharami

Guilan University of Medical Sciences

Sharami@gums.ac.ir+98 13 1322 5624

Outcome results

None listed

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