Recruiting

Observational Study

Sponsor:

The Woman's Hospital of Texas

Code:

NCT00782665

Conditions

Infection

Eligibility Criteria

Sex: Female

Age: 18 - 48

Healthy Volunteers: Accepted

Interventions

Biopsy

Study Details

Brief summary:

This study is designed to demonstrate that women in labor become infected without exhibiting any clinical signs or symptoms of infection.

Conditions

Infection

Study ID

NCT00782665

Start date

Jul, 2008

Status verified date

Oct, 2008

Completion date

Jul, 2010

Anticipated

Primary completion date

Jun, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 48

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Patients must be afebrile throughout labor.
2. Amniotic fluid must be not purulent; presence of meconium is not an exclusion.
3. Patients undergoing an elective cesarean section.
4. Patients who have labored with intact or ruptured amniotic membranes.

Exclusion Criteria:

1. Patient with a temperature of ≥ 100.4o F.
2. White blood cell count ≥ 24,000.
3. Suspicion of chorioamnionitis.
4. Suspicion of a urinary tract infection.
5. Presence of diarrhea (defined > 4 liquid stools in a 24 hour period).
6. Patient currently taking therapeutic antibiotics.

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group 1

Patients who have labored and subsequently delivered by cesarean section

placebo comparator: 2

Patients who electively select cesarean section

Interventions

Biopsy

1 centimeter x 1/2 centimeter piece cut from uterus

Primary outcome measure

  • Postoperative infection following rupture of amniotic membranes [ Time Frame: Amount of time it takes to obtain culture result ]

Central Contacts and Locations

Locations

The Woman's Hospital of Texas

Recruiting

Houston, Texas, United States, 77054

Contacts

Donna Roth, BA

713-791-7129Donna.Roth@HCAhealthcare.com

Principal Investigator:

Sebastian Faro, MD, PhD

More Information

Sponsor

The Woman's Hospital of Texas

Last update posted

Oct 31, 2008

Last verified

Oct, 2008

Keywords

  • postoperative
  • infection
  • c-section

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Woman's Hospital of Texas on 2008-10-31.