Progesterone and Second Trimester Bleeding

NCT01269450 | Terminated DMC

• 1 other identifier: 0023-08-EMC
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

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.

Conditions

Antepartum Bleeding; Preterm Birth

Keywords

second trimester vaginal bleeding; late abortion; preterm birth; progesterone

Outcome Measures

Primary Outcomes (1)

• Incidence of spontaneous preterm birth - before 37 weeks.

  3 years

Secondary Outcomes (1)

• Maternal and fetal outcomes

  3 years

Study Arms (2)

Utrogestan

ACTIVE COMPARATOR

Drug: micronized progesterone 200 mg (Utrogestan)

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

micronized progesterone 200 mg (Utrogestan) DRUG

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

Utrogestan

placebo DRUG

placebo 200mg vaginal tablets

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Viable pregnancy
• Gestational age between 13 to 26 weeks
• Vaginal bleeding from uterine origin
• Singleton pregnancy
• Normal clotting tests
• Hemodynamically stable woman

You may not qualify if:

• 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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (3)

Emek medical center

Afula, 18101, Israel

Location

dEP ob/gyn, Hillel Yaffe Medical Center.

Hadera, Israel

Location

Dep. OB/GYN, The Nazareth Hospital, E.M.M.S

Nazareth, Israel

Location

Related Publications (1)

• 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.

  PMID: 31087325 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone; Utrogestan

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• RAED SALIM, MD

  HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 4, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: July 1, 2017
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

IL (3)