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NCT01269450 Clinical Trial

Progesterone and Second Trimester Bleeding

Preterm Birth Clinical Trial

Official title:
The Impact of Progesterone on the Risk of Preterm Birth Among Women With Second Trimester Bleeding. A Double Blind Placebo Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01269450
Other study ID # 0023-08-EMC
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 2011
Est. completion date July 2017

Study information
Verified date June 2018
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 128
Est. completion date July 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• micronized progesterone 200 mg (Utrogestan)
micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily
• placebo
placebo 200mg vaginal tablets

Locations
Country Name City State
Israel 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

Sponsors (1)
Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of spontaneous preterm birth - before 37 weeks. 3 years
Secondary Maternal and fetal outcomes 3 years
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