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Progesterone and Second Trimester Bleeding

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ClinicalTrials.gov Identifier: NCT01269450
Recruitment Status : Recruiting
First Posted : January 4, 2011
Last Update Posted : September 2, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Antepartum Bleeding Preterm Birth Drug: micronized progesterone 200 mg (Utrogestan) Drug: placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : December 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Utrogestan Drug: micronized progesterone 200 mg (Utrogestan)
micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily
Placebo Comparator: placebo Drug: placebo
placebo 200mg vaginal tablets

Outcome Measures

Primary Outcome Measures :
  1. Incidence of spontaneous preterm birth - before 37 weeks. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Maternal and fetal outcomes [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269450

Contact: RAED SALIM, MD 97246494355 salim_ra@clalit.org.il
Contact: GALI GARMI, MD 97246494355 galit_ga@clalir.org.il

Emek medical center Recruiting
Afula, Israel, 18101
Contact: Raed Salim, MD    97246494031    salim_ra@clalit.org.il   
Principal Investigator: Manal Massalha, MD         
dEP ob/gyn, Hillel Yaffe Medical Center. Recruiting
Hadera, Israel
Contact: Ilan Bruchim, MD       ilan.bruchim@gmail.com   
Dep. OB/GYN, The Nazareth Hospital, E.M.M.S Recruiting
Nazareth, Israel
Contact: Marwan Hakim, MD       marwanhakim@nazhosp.com   
Principal Investigator: Marwan Hakim, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Principal Investigator: RAED SALIM, MD HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel
More Information

Additional Information:
Responsible Party: Raed Salim, Dr., HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01269450     History of Changes
Other Study ID Numbers: 0023-08-EMC
First Posted: January 4, 2011    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016

Keywords provided by Raed Salim, HaEmek Medical Center, Israel:
second trimester vaginal bleeding
late abortion
preterm birth

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Pathologic Processes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs