Antibiotics and the Prolongation of Pregnancy in Preterm Labor With an Advanced Cervical Exam
Information source: MetroHealth Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Length of Pregnancy Prolongation in Hours
Intervention: erythromycin and metronidazole (antibiotics) (Drug); placebo (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: MetroHealth Medical Center Official(s) and/or principal investigator(s):
Brian Mercer, M.D., Principal Investigator, Affiliation: MetroHealth Medical Center MFM Director
Thaddeus Waters, M.D., Principal Investigator, Affiliation: MetroHealth Medical Center
Summary
Preterm birth, its causes, prevention, complications and ramifications persist as an
important focus of obstetrical research. In the United States 11. 8% of all live births occur
prior to 37 weeks gestation. As many as 45% of these deliveries will have been proceeded by
preterm labor with intact membranes.(2) Both preterm labor and preterm premature rupture of
membranes have both been associated with evidence intrauterine infection. While antibiotic
treatment in conservative management of preterm PROM remote from term has been shown to
significantly prolong pregnancy and reduce infant morbidity, (16) data regarding the
effectiveness of antibiotics for pregnancy prolongation in preterm labor are inconsistent.
(3-15) Currently, narrow spectrum antibiotics (penicillin or clindamycin) are given prior to
delivery to reduce the risk of neonatal Group B Beta Streptococcus (GBS) sepsis, however
broad spectrum antibiotic treatment of women with preterm labor for pregnancy prolongation is
not recommended.
Review of the literature regarding antibiotic treatment for pregnancy prolongation in preterm
labor reveals that most studies utilized single agent therapy, and no study has evaluated the
use of antibiotics for pregnancy prolongation in women with an advanced cervical exam (>4cm).
While a number of studies have shown significant pregnancy prolongation in unselected
populations,(5,12,13) only one study of 12 reviewed was able to show a neonatal benefit to
adjunctive antibiotic use.(12,20) Norman, et al was able to show a reduction in the incidence
of necrotising enterocolitis with the use of antibiotics. Given the number of studies in this
area, and the lack of supporting evidence, this likely represents an alpha error. Another
study by Svare et al was able to show a significant decrease in NICU admissions for women
treated with antibiotics in the setting of preterm labor, however no change was reported in
neonatal morbidities.
Our proposed study is designed to evaluate patients at particular risk for preterm delivery;
those with advanced cervical exam. In this randomized prospective controlled study, we intend
to examine the influence of adjunctive antibiotic use in preterm labor complicated by a
cervical exam of 4 cm or greater. We plan to compare a study group receiving broad-spectrum
antibiotics with a control group that will not receive antibiotics for pregnancy
prolongation. Both groups will receive antibiotics for GBS prophylaxis as indicated. We hope
to see a delay in delivery in the study group as a primary outcome. Secondary outcomes will
include the use of steroids, neonatal complications including sepsis, intraventricular
hemorrhage, periventricular leukomalacea, mechanical ventilation and respiratory distress
syndrome, retinopathy of prematurity and necrotizing enterocolitis, and neonatal ICU stay.
Clinical Details
Official title: Antibiotics and the Prolongation of Pregnancy in Preterm Labor With an Advanced Cervical Exam
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Length of pregnancy prolongation
Secondary outcome: Respiratory distress
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. All patients admitted with the diagnosis of preterm labor between 24 0/7 and 33 6/7
weeks gestation. Preterm labor will be defined by regular contractions and/or cervical
change from last documented exam.
2. Cervical exam 4 cm or greater
3. Intact membranes
Exclusion Criteria:
1. Multiple gestation (>2)
2. Clinical evidence of chorioamnionitis, such as maternal fever, uterine tenderness,
fetal tachycardia
3. Lethal fetal anomaly
4. Persistent vaginal bleeding, abruption, or placenta previa
5. Rupture of membranes
6. Maternal illness or fetal indication requiring delivery
7. Inability to give informed consent
8. Serious allergy to study medications. GI discomfort will not be considered a drug
allergy
Locations and Contacts
MetroHealth Medical Center, Cleveland, Ohio 44109, United States
Additional Information
Starting date: December 2007
Last updated: January 8, 2008
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