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Progesterone and Second Trimester Bleeding

This study is currently recruiting participants.
Verified March 2013 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01269450
First received: January 3, 2011
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Antepartum Bleeding
Preterm Birth
 Drug: micronized progesterone 200 mg (Utrogestan)
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Incidence of spontaneous preterm birth - before 37 weeks. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal and fetal outcomes [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 268
Study Start Date: December 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269450

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

Locations
Israel
Emek medical center Recruiting
Afula, Israel, 18101
Contact: Raed Salim, MD     97246494031     salim_ra@clalit.org.il    
Principal Investigator: RAED SALIM, MD            
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
Investigators
Principal Investigator: RAED SALIM, MD HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel
  More Information

Additional Information:
Dep OB/GY, Emek Medical Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Raed Salim, Dr., HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01269450     History of Changes
Other Study ID Numbers: 0023-08-EMC
Study First Received: January 3, 2011
Last Updated: March 19, 2013
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Hemorrhage
Premature Birth
Uterine Hemorrhage
Obstetric Labor Complications
Pathologic Processes
Obstetric Labor, Premature
Pregnancy Complications
Uterine Diseases
 Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013