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Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

NCT ID: NCT02438371

Last Updated: 2021-11-24

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2019-10-10

Brief Summary

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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

Detailed Description

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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

Conditions

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Preterm Labor

Keywords

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pregnancy preterm labor tocolysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nifedipine

Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours for a total of 48 hours.

Group Type ACTIVE_COMPARATOR

Nifedipine

Intervention Type DRUG

Nifedipine plus Indomethacin

Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours for a total of 48 hours.

Group Type ACTIVE_COMPARATOR

Nifedipine

Intervention Type DRUG

Indomethacin

Intervention Type DRUG

Interventions

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Nifedipine

Intervention Type DRUG

Indomethacin

Intervention Type DRUG

Other Intervention Names

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Procardia

Eligibility Criteria

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Inclusion Criteria

* We will include pregnant women between 22 0/7 to 31 6/7 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 of at least 1 cm or
* cervical dilation of 2 cm at the time of initial exam or
* positive fetal fibronectin and 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 the past 48 hours
* known adverse effect to indomethacin or nifedipine
* already receiving nifedipine for chronic hypertension
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Jerrie Refuerzo

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Hutchinson, M.S.

Role: STUDY_DIRECTOR

The University of Texas Health Science Center, Houston

Locations

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Memorial Hermann Hospital Texas Medical Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.

Reference Type DERIVED
PMID: 35947046 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HSC-MS-15-0134

Identifier Type: -

Identifier Source: org_study_id