Progesterone and Second Trimester Bleeding

ID: NCT01269450
Status: Terminated
Phase: N/A
Start Date: December 01, 2010
First Submitted: January 03, 2011
Last Updated: January 20, 2018
Results: N/A
Sponsors & Collaborators: HaEmek Medical Center, Israel
Location: Israel
Conditions: Antepartum Bleeding, Preterm Birth
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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.

Detailed Description

Condition or disease Intervention/treatment Phase

Antepartum Bleeding

Preterm Birth

Drug: micronized progesterone 200 mg (Utrogestan)
Other Names
Drug: placebo
Other Names
N/A

Tracking Information

First Submitted DateJanuary 03, 2011
Last Update Posted DateJanuary 20, 2018
Start DateDecember 01, 2010
Actual Completion DateJuly 01, 2017
Primary Completion DateJanuary 01, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Incidence of spontaneous preterm birth - before 37 weeks. [Time Frame: 3 years]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Maternal and fetal outcomes [Time Frame: 3 years]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleProgesterone and Second Trimester Bleeding
Official TitleThe Impact of Progesterone on the Risk of Preterm Birth Among Women With Second Trimester Bleeding. A Double Blind Placebo Controlled Trial
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.

Detailed Description

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
128
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Prevention
Conditions
Antepartum Bleeding
Preterm Birth
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: micronized progesterone 200 mg (Utrogestan)

micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily

Other Names
Drug: placebo

placebo 200mg vaginal tablets

Other Names
Study Groups/Cohorts
Utrogestan

placebo

Study Arms
Placebo Comparator placebo
Drug : placebo
placebo 200mg vaginal tablets

Active Comparator Utrogestan
Drug : micronized progesterone 200 mg (Utrogestan)
micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily

Arm Intervention/Treatment
Placebo Comparator placebo
Drug : placebo
Active Comparator Utrogestan
Drug : micronized progesterone 200 mg (Utrogestan)

Recruitment Information

Recruitment Status:Terminated
Enrollment128
Completion DateJuly 01, 2017
Eligibility 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
GenderFemale
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Israel

Administrative Information

NCT Number:NCT01269450
Other Study ID Numbers
0023-08-EMC
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyRaed Salim, HaEmek Medical Center, Israel
Study Sponsor
HaEmek Medical Center, Israel
Collaborators
Not Available
Investigators
Principal Investigator
RAED SALIM, MD
HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel