Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Preterm Birth; Obstetric Labor, Premature	Drug: 17 α hydroxyprogesterone caproate; Drug: Placebo	Phase 3

Detailed Description:

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 17 α hydroxyprogesterone caproate; 17α-Hydroxyprogesterone caproate.	Drug: 17 α hydroxyprogesterone caproate; 250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.
Placebo Comparator: Placebo; Saline solution.	Drug: Placebo; 250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.; Other Name: Saline solution

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Incidence of preterm birth (before 37 weeks of gestation) [ Time Frame: 18 months ]
   Number of patients that delivered before 37 weeks of pregnancy

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

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)

Sponsors and Collaborators

Saint Thomas Hospital, Panama

Investigators

Principal Investigator:	Osvaldo A Reyes, MD (Gyn/Ob)	Saint Thomas Maternity Hospital
Principal Investigator:	Rodrigo Velarde, MD (Gyn/Ob)	Saint Thomas Maternity Hospital

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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