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Progesterone and Second Trimester Bleeding

Information source: HaEmek Medical Center, Israel
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Antepartum Bleeding; Preterm Birth

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

Phase: N/A

Status: Recruiting

Sponsored by: HaEmek Medical Center, Israel

Official(s) and/or principal investigator(s):
RAED SALIM, MD, Principal Investigator, Affiliation: HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel

Overall contact:
RAED SALIM, MD, Phone: 97246494355, Email: salim_ra@clalit.org.il

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Incidence of spontaneous preterm birth - before 37 weeks.

Secondary outcome: Maternal and fetal outcomes

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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 and Contacts

RAED SALIM, MD, Phone: 97246494355, Email: salim_ra@clalit.org.il

Emek medical center, Afula 18101, Israel; Recruiting
Raed Salim, MD, Phone: 97246494031, Email: salim_ra@clalit.org.il
RAED SALIM, MD, Principal Investigator

Dep. OB/GYN, The Nazareth Hospital, E.M.M.S, Nazareth, Israel; Recruiting
Marwan Hakim, MD, Email: marwanhakim@nazhosp.com
Marwan Hakim, MD, Principal Investigator

Additional Information

Dep OB/GY, Emek Medical Center

Starting date: December 2010
Last updated: March 20, 2015

Page last updated: August 23, 2015

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