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Progesterone and Second Trimester Bleeding

Primary Purpose

Antepartum Bleeding, Preterm Birth

Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
micronized progesterone 200 mg (Utrogestan)
placebo
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antepartum Bleeding focused on measuring second trimester vaginal bleeding, late abortion, preterm birth, progesterone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Emek medical center
  • dEP ob/gyn, Hillel Yaffe Medical Center.
  • Dep. OB/GYN, The Nazareth Hospital, E.M.M.S

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Utrogestan

placebo

Arm Description

Outcomes

Primary Outcome Measures

Incidence of spontaneous preterm birth - before 37 weeks.

Secondary Outcome Measures

Maternal and fetal outcomes

Full Information

First Posted
January 3, 2011
Last Updated
June 5, 2018
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT01269450
Brief Title
Progesterone and Second Trimester Bleeding
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 Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
March 2011 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antepartum Bleeding, Preterm Birth
Keywords
second trimester vaginal bleeding, late abortion, preterm birth, progesterone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Utrogestan
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
micronized progesterone 200 mg (Utrogestan)
Intervention Description
micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo 200mg vaginal tablets
Primary Outcome Measure Information:
Title
Incidence of spontaneous preterm birth - before 37 weeks.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Maternal and fetal outcomes
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RAED SALIM, MD
Organizational Affiliation
HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emek medical center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
dEP ob/gyn, Hillel Yaffe Medical Center.
City
Hadera
Country
Israel
Facility Name
Dep. OB/GYN, The Nazareth Hospital, E.M.M.S
City
Nazareth
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
31087325
Citation
Salim R, Hakim M, Zafran N, Nachum Z, Romano S, Garmi G. Double-blind randomized trial of progesterone to prevent preterm birth in second-trimester bleeding. Acta Obstet Gynecol Scand. 2019 Oct;98(10):1318-1325. doi: 10.1111/aogs.13641. Epub 2019 Jun 1.
Results Reference
derived
Links:
URL
http://hospitals.clalit.co.il/hospitals/emek/he-il/Clinics/GynecologyAndDelivery/Pages/WomenAndBirthDepartment.aspx
Description
Dep OB/GY, Emek Medical Center

Learn more about this trial

Progesterone and Second Trimester Bleeding

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