Progesterone and Second Trimester Bleeding | NCT01269450

Studies
Progesterone and Second Trimester Bleeding

NCT01269450

Sponsor

HaEmek Medical Center, Israel

Status

Terminated

Last Update Posted

Jun 6, 2018Actual

Enrollment

128Actual

Phase

Not Applicable

Conditions

Antepartum Bleeding
Preterm Birth

Interventions

micronized progesterone 200 mg (Utrogestan)
placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment

Expanded Access Info

Start Date

Mar 2011Actual

Primary Completion Date

Jan 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Jan 3, 2011

First Submission Date that Met QC Criteria

Jan 3, 2011

First Posted Date

Jan 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2018

Last Update Posted Date

Jun 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Utrogestan	Active Comparator		Drug: micronized progesterone 200 mg (Utrogestan)
placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
micronized progesterone 200 mg (Utrogestan)	Drug	micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily	Utrogestan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of spontaneous preterm birth - before 37 weeks.		3 years

Secondary Outcomes

Measure	Description	Time Frame
Maternal and fetal outcomes		3 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
RAED SALIM, MD	HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emek medical center		Afula		18101	Israel
dEP ob/gyn, Hillel Yaffe Medical Center.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31087325	Derived	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.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473