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

NCT00589329 | Terminated Results DMC

• 1 other identifier: IRB01-00012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm birth remains a major health concern affecting up to 12% of all live births prior to 37 weeks gestation. As preterm birth can often be associated with infection our proposal is to evaluate in a randomized fashion antibiotics for women with advanced cervical exams.

Conditions

Length of Pregnancy Prolongation in Hours

Keywords

Preterm birth; antibiotics; preterm labor; respiratory distress; pergnancy

Outcome Measures

Primary Outcomes (1)

• Length of Pregnancy Prolongation

  The length of time (in hours) from initiation of therapy to delivery will establish the latency

  Measured from randomization to delivery in hours

Secondary Outcomes (1)

• Respiratory Distress

  newborn nursery

Study Arms (2)

A

EXPERIMENTAL

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)

B

PLACEBO COMPARATOR

Group B will not receive antibiotics for pregnancy prolongation, but will receive a matching masked placebo (IV saline and pill) regimen.

Drug: placebo

Interventions

erythromycin and metronidazole (antibiotics) DRUG

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

A

placebo DRUG

IV and pill placebo

B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Cervical exam 4 cm or greater
• Intact membranes

You may not qualify if:

• Multiple gestation (\>2)
• Clinical evidence of chorioamnionitis, such as maternal fever, uterine tenderness, fetal tachycardia
• Lethal fetal anomaly
• Persistent vaginal bleeding, abruption, or placenta previa
• Rupture of membranes
• Maternal illness or fetal indication requiring delivery
• Inability to give informed consent
• Serious allergy to study medications. GI discomfort will not be considered a drug allergy

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature; Dyspnea

Interventions

Erythromycin; Metronidazole; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Larraine Presley
• Organization: MetroHealth Medical CEnter

lpresley@metrohealth.org

216-778-8927

Study Officials

• Brian Mercer, M.D.

  MetroHealth Medical Center MFM Director

  PRINCIPAL INVESTIGATOR

• Thaddeus Waters, M.D.

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MFM attending, metroheatlh

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 9, 2008
• Study Start: December 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-08

Locations

US (1)