Progesterone and Second Trimester Bleeding
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ClinicalTrials.gov Identifier: NCT01269450 |
Recruitment Status
:
Terminated
(Slow recruitment)
First Posted
: January 4, 2011
Last Update Posted
: January 23, 2018
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Antepartum Bleeding Preterm Birth | Drug: micronized progesterone 200 mg (Utrogestan) Drug: placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 128 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | January 2017 |
Actual Study Completion Date : | July 2017 |

Arm | Intervention/treatment |
---|---|
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
|
- Incidence of spontaneous preterm birth - before 37 weeks. [ Time Frame: 3 years ]
- Maternal and fetal outcomes [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269450
Israel | |
Emek medical center | |
Afula, Israel, 18101 | |
dEP ob/gyn, Hillel Yaffe Medical Center. | |
Hadera, Israel | |
Dep. OB/GYN, The Nazareth Hospital, E.M.M.S | |
Nazareth, Israel |
Principal Investigator: | RAED SALIM, MD | HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel |
Additional Information:
Responsible Party: | Raed Salim, Dr., HaEmek Medical Center, Israel |
ClinicalTrials.gov Identifier: | NCT01269450 History of Changes |
Other Study ID Numbers: |
0023-08-EMC |
First Posted: | January 4, 2011 Key Record Dates |
Last Update Posted: | January 23, 2018 |
Last Verified: | January 2018 |
Keywords provided by Raed Salim, HaEmek Medical Center, Israel:
second trimester vaginal bleeding late abortion preterm birth progesterone |
Additional relevant MeSH terms:
Premature Birth Hemorrhage Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Pathologic Processes |
Progesterone Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |