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Antibiotics and the Prolongation of Pregnancy in Preterm Labor With an Advanced Cervical Exam

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ClinicalTrials.gov Identifier: NCT00589329
Recruitment Status : Terminated (published data suggest potential harm in other investigations.)
First Posted : January 9, 2008
Last Update Posted : October 24, 2012
Sponsor:
Information provided by (Responsible Party):
Thaddeus Waters, MetroHealth Medical Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Length of Pregnancy Prolongation in Hours Drug: erythromycin and metronidazole (antibiotics) Drug: placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antibiotics and the Prolongation of Pregnancy in Preterm Labor With an Advanced Cervical Exam
Study Start Date : December 2007
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: A

roup A will be assigned to receive antibiotics:

  • Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days.
  • Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days.
 Drug: erythromycin and metronidazole (antibiotics)

Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days.

Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days
Placebo Comparator: B
Group B will not receive antibiotics for pregnancy prolongation, but will receive a matching masked placebo (IV saline and pill) regimen.
 Drug: placebo
IV and pill placebo


Outcome Measures
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Primary Outcome Measures :
  1. Length of pregnancy prolongation [ Time Frame: Measured from randomization to delivery ]

Secondary Outcome Measures :
  1. Respiratory distress [ Time Frame: newborn nursery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00589329


Locations
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
Principal Investigator: Brian Mercer, M.D. MetroHealth Medical Center MFM Director
Principal Investigator: Thaddeus Waters, M.D. MetroHealth Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Thaddeus Waters, MFM attending, metroheatlh, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00589329     History of Changes
Other Study ID Numbers: IRB01-00012
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: October 24, 2012
Last Verified: October 2012

Keywords provided by Thaddeus Waters, MetroHealth Medical Center:
Preterm birth
antibiotics
preterm labor
respiratory distress
pergnancy

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Anti-Bacterial Agents
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Antibiotics, Antitubercular
 Metronidazole
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action