Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone
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ClinicalTrials.gov Identifier: NCT01317225 |
Recruitment Status
: Unknown
Verified January 2015 by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama.
Recruitment status was: Recruiting
First Posted
: March 17, 2011
Last Update Posted
: January 6, 2015
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Condition or disease | Intervention/treatment | Phase |
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Preterm Birth Obstetric Labor, Premature | Drug: 17 α hydroxyprogesterone caproate Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Use of 17α Hydroxyprogesterone Caproate for the Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor During Current Pregnancy. Double Blind, Randomized, Controlled Trial. |
Study Start Date : | June 2011 |
Estimated Primary Completion Date : | July 2015 |
Estimated Study Completion Date : | August 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: 17 α hydroxyprogesterone caproate
17α-Hydroxyprogesterone caproate.
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Drug: 17 α hydroxyprogesterone caproate
250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.
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Placebo Comparator: Placebo
Saline solution.
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Drug: Placebo
250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.
Other Name: Saline solution
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- Incidence of preterm birth (before 37 weeks of gestation) [ Time Frame: 18 months ]Number of patients that delivered before 37 weeks of pregnancy
- Incidence of preterm birth before 35 weeks of pregnancy [ Time Frame: 18 months ]To determine if the use of 17 α hydroxyprogesterone caproate can reduce the incidence of preterm birth before 35 weeks of gestation in patients with a previous episode of threatened preterm labor.
- Incidence of preterm birth before 32 weeks of pregnancy [ Time Frame: 18 months ]To determine if the use of 17 α hydroxyprogesterone caproate can reduce the incidence of preterm birth before 32 weeks of gestation in patients with a previous episode of threatened preterm labor.

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pregnant women between 26 and 34 weeks of gestation.
- Cervical length (determined by transvaginal ultrasound) below the 10th percentile for the gestational age.
Exclusion Criteria:
- Multiple gestations.
- Maternal pathologies in which preterm termination of pregnancy is required.

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): NCT01317225
Contact: Osvaldo A Reyes, MD (Gyn/Ob) | 011(507)65655041 | oreyesmaternidad@gmail.com | |
Contact: Rodrigo Velarde, MD (Gyn/Ob) | 011(507)66159954 | revelarde_14@yahoo.es |
Panama | |
Saint Thomas Maternity Hospital | Recruiting |
Panama, Panama | |
Contact: Osvaldo A Reyes, MD (Gyn/Ob) 011(507)65655041 oreyesmaternidad@gmail.com | |
Contact: Rodrigo Velarde, MD (Gyn/Ob) 011(507)66159954 revelarde_14@yahoo.es | |
Principal Investigator: Osvaldo A Reyes, MD (Gyn/Ob) | |
Principal Investigator: Rodrigo Velarde, MD (Gyn/Ob) |
Principal Investigator: | Osvaldo A Reyes, MD (Gyn/Ob) | Saint Thomas Maternity Hospital | |
Principal Investigator: | Rodrigo Velarde, MD (Gyn/Ob) | Saint Thomas Maternity Hospital |
Responsible Party: | Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama |
ClinicalTrials.gov Identifier: | NCT01317225 History of Changes |
Other Study ID Numbers: |
MHST2011-01 |
First Posted: | March 17, 2011 Key Record Dates |
Last Update Posted: | January 6, 2015 |
Last Verified: | January 2015 |
Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Progesterone Obstetric labor, premature Short cervix |
Additional relevant MeSH terms:
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Progesterone 17-alpha-hydroxy-progesterone caproate 11-hydroxyprogesterone |
Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Estrogen Antagonists Hormone Antagonists |