Progesterone and Second Trimester Bleeding

HaEmek Medical Center, Israel128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

128

Conditions

Antepartum Bleeding Preterm Birth

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Emek medical center

Afula, Israel

dEP ob/gyn, Hillel Yaffe Medical Center.

Hadera, Israel

Dep. OB/GYN, The Nazareth Hospital, E.M.M.S

Nazareth, Israel

Outcomes

Primary Outcomes

Incidence of spontaneous preterm birth - before 37 weeks.

Time frame: 3 years

Secondary Outcomes

Maternal and fetal outcomes

Time frame: 3 years