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The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone biweekly can reduce the incidence of preterm labor in patients with an episode of threatened preterm labor during the current pregnancy.
Preterm birth is one of the main causes of neonatal mortality and morbidity around the world, with serious repercussions on the health system and the families of the preterm baby. Many drugs have been evaluated with the purpose of preventing preterm birth in the patient at risk. One of these drugs is 17 α hydroxyprogesterone caproate. The purpose of this study is to evaluate if the use of biweekly doses of 17 α hydroxyprogesterone caproate in patients hospitalized with the diagnosis of threatened preterm labor, defined as the presence of uterine contractions and a short cervix (below the 10th percentile for the gestational age), can reduce the incidence of preterm birth in this high risk group population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 17 α hydroxyprogesterone caproate | Experimental | 17α-Hydroxyprogesterone caproate. |
|
| Placebo | Placebo Comparator | Saline solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17 α hydroxyprogesterone caproate | Drug | 250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of preterm birth (before 37 weeks of gestation) | Number of patients that delivered before 37 weeks of pregnancy | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of preterm birth before 35 weeks of pregnancy | 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. | 18 months |
| Incidence of preterm birth before 32 weeks of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Osvaldo A Reyes, MD (Gyn/Ob) | Contact | 011(507)65655041 | oreyesmaternidad@gmail.com | |
| Rodrigo Velarde, MD (Gyn/Ob) | Contact | 011(507)66159954 | revelarde_14@yahoo.es |
| Name | Affiliation | Role |
|---|---|---|
| Osvaldo A Reyes, MD (Gyn/Ob) | Saint Thomas Maternity Hospital | Principal Investigator |
| Rodrigo Velarde, MD (Gyn/Ob) | Saint Thomas Maternity Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Thomas Maternity Hospital | Recruiting | Panama City | Provincia de Panamá | Panama |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Placebo | Drug | 250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery. |
|
|
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. |
| 18 months |