Progesterone and Second Trimester Bleeding
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2014 by HaEmek Medical Center, Israel
Sponsor:
HaEmek Medical Center, Israel
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01269450
First received: January 3, 2011
Last updated: September 7, 2014
Last verified: September 2014
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
Bleeding
Drug Information available for:
Progesterone
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 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269450
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:
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: | September 7, 2014 |
| 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:
|
Premature Birth Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Progesterone |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs Progestins |
ClinicalTrials.gov processed this record on March 03, 2015