TerminatedNot Applicable

Progesterone and Second Trimester Bleeding

Stopped: Slow recruitment

Israel128 participantsStarted 2011-03

Plain-language summary

Working hypothesis and aims: To investigate whether progesterone treatment affects the incidence of preterm labor compared to placebo, among women with 2nd trimester bleeding. The participants will be allocated through randomization to a study or control group. Women in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an intra-vaginal tablet once daily while the control group will receive placebo. Both women and medical staff will be blinded to group allocation. Treatment will commence on the day of inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation. Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal outcome.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Viable pregnancy * Gestational age between 13 to 26 weeks * Vaginal bleeding from uterine origin * Singleton pregnancy * Normal clotting tests * Hemodynamically stable woman Exclusion Criteria: * Water leak * Signs of preterm labor * Fetal malformations incompatible with life * Uterine malformations and other maternal conditions, i.e. liver disease, breast cancer, active thromboembolic state * Past preterm birth

What they're measuring

Incidence of spontaneous preterm birth - before 37 weeks.

Timeframe: 3 years

Trial details

NCT IDNCT01269450

SponsorHaEmek Medical Center, Israel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01

View on ClinicalTrials.gov More Antepartum Bleeding trials