Progesterone and Second Trimester Bleeding

HaEmek Medical Center, Israel

Status: Terminated

Conditions: Antepartum Bleeding; Preterm Birth

Treatments: Drug: micronized progesterone 200 mg (Utrogestan); Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01269450

0023-08-EMC

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 2 patient groups, including a placebo group

Utrogestan

Active Comparator group

Treatment:

Drug: micronized progesterone 200 mg (Utrogestan)

placebo

Placebo Comparator group

Treatment:

Drug: placebo