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Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

Information source: The University of Texas Health Science Center, Houston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preterm Labor

Intervention: Nifedipine (Drug); Indomethacin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: The University of Texas Health Science Center, Houston

Official(s) and/or principal investigator(s):
Maria Hutchinson, M.S., Study Director, Affiliation: The University of Texas Health Science Center, Houston

Overall contact:
Jerrie Refuerzo, M.D., Phone: 713-500-6416, Email: jerrie.s.refuerzo@uth.tmc.edu

Summary

Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor

Clinical Details

Official title: Nifedipine Alone or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor: An Open Label, Randomized Comparative Effectiveness Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The percentage of women who remain pregnant

Secondary outcome: Length of pregnancy

Detailed description: The investigators current treatment for preterm labor has not been shown to be effective in prolonging pregnancy sufficiently to improve neonatal outcomes and other treatment strategies are needed. Multiple examples demonstrate that multi-agent treatments are routine clinical practice in other fields of medicine including chemotherapeutics for cancer, multi-therapeutics for myocardial infarction and broad spectrum antibiotics for pneumonia. At this time, it is unclear if a combination of tocolytic medications for preterm labor is more advantageous for women. If pregnancy is prolonged with combined tocolytic therapy, this could directly influence the treatment of preterm labor and potentially improve neonatal outcomes. There currently are no trials of combination regimens using widely used tocolytic agents, such as nifedipine and indomethacin. Thus, we propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- We will include pregnant women between 220/7 to 316/7 weeks gestation who present

with regular uterine contractions defined as at least one contraction every 10 minutes for 30 minutes with at least one of the following:

- cervical change or

- 2 cm dilated or

- positive fetal fibronectin or

- transvaginal cervical length <2. 5 cm

Exclusion Criteria:

- We will exclude pregnant women with any contraindication to tocolysis:

- clinical chorioamnionitis (defined as a temperature of >100. 4 F and any of the

following: fundal tenderness, maternal tachycardia, fetal tachycardia or purulent vaginal discharge)

- non reassuring fetal heart tones

- suspected placental abruption

- preterm premature rupture of membranes

- prior tocolytic treatment during their pregnancy

- known adverse effect to indomethacin or nifedipine

Locations and Contacts

Jerrie Refuerzo, M.D., Phone: 713-500-6416, Email: jerrie.s.refuerzo@uth.tmc.edu

Memorial Hermann Hospital Texas Medical Center, Houston, Texas 77030, United States; Recruiting
Jerrie S Refuerzo, M.D., Phone: 713-500-6416, Email: Jerrie.S.Refuerzo@uth.tmc.edu
Maria Hutchinson, M.S, Phone: 713-500-5850, Email: Maria.S.Keefer@uth.tmc.edu
Jerrie S Refuerzo, M.D., Principal Investigator
Additional Information

Starting date: May 2015
Last updated: May 11, 2015

Page last updated: August 23, 2015

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