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Evaluation of the effect of progesterone on latency period of preterm premature rupture of membrane

Evaluation of the effect of progesterone on latency period of preterm premature rupture of membrane in 24-34 weeks of gestation

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014020216453N1
Enrollment
171
Registered
2014-03-12
Start date
2012-03-20
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

preterm premature rapture of membrane in pregnant women. Premature rupture of membranes

Interventions

Intervention 1: In intervention group I, 400 mg suppository progesterone (made by Aboreyhan company) is administered daily until the end of pregnancy. Intervention 2: In intervention group II, 250 mg
Treatment - Drugs
In intervention group I, 400 mg suppository progesterone (made by Aboreyhan company) is administered daily until the end of pregnancy.
In intervention group II, 250 mg hydroxy progesterone (MADE BY BIOTECK COMPANY, each ampoule contains 250 mg/ml) is injected IM every week until the end of pregnancy.
Control group receives no medication.

Sponsors

Research chancelor of kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: obvious fluid passage or direct observation with speculum or by positive nitrazine test in gestational age of 24 to 34 week - according to first trimester sonography or last menstrual period. Exclusion criteria: anomalous fetus? multiple gestation? chorioamnionitis signs at the time of admission? fetal distress? abruptio placenta? placenta previa? IUGR? medical diseases of mother (DM, severe preeclampsia).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Latency period. Timepoint: from the time of rupture of membrane to delivery. Method of measurement: days from rupture of membrane to delivery.

Secondary

MeasureTime frame
Chorioamnionitis. Timepoint: during Latency period. Method of measurement: abdominal tenderness,fever,mother and fetal tachycardia and rise of WBC count.;Neonatal sepsis. Timepoint: neonatal period. Method of measurement: fever ;malase;poor feeding;increased white blood cell ;positive blood or spinal fluid culture.;Parity. Timepoint: during the study. Method of measurement: NVD Number.;Amniotic fluid volume. Timepoint: in latency period. Method of measurement: by sonography.;Fetal death. Timepoint: in latency period. Method of measurement: The number of fetal deaths.;Age. Timepoint: in sampling period. Method of measurement: patients' age in year.;Neonatal death. Timepoint: neonatal period. Method of measurement: The number of neonatal deaths.;Neonatal admission in intensive care unit. Timepoint: The neonatal period. Method of measurement: the number of neonatal admission.;Fifth minute apgar score. Timepoint: neonatal birth time. Method of measurement: Sum of five components OF APGAR SCORING SYSTEM.;Delivery method. Timepoint: Delivery time. Method of measurement: sum of number of normal vaginal delivery and sum of number of cesarean delivery.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFateme Mirzaii

Kerman University of Medical Sciences

mirzaie_fatemeh@yahoo.coms.moradi@fums.ac.irs.moradi@fums.ac.ir+34 13222250

Outcome results

None listed

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