Back to resultsNifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor
Primary Purpose
Preterm Labor
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nifedipine
Indomethacin
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Labor focused on measuring pregnancy, preterm labor, tocolysis
Eligibility Criteria
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
Sites / Locations
- Memorial Hermann Hospital Texas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nifedipine
Nifedipine plus Indomethacin
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation
Secondary Outcome Measures
Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation
Number of Days From First Dose of Tocolytic Agent to Delivery
Length of time from tocolytic initiation to the time of delivery
Neonatal Birthweight
Neonatal Sex
Number of Neonates Who Were Admitted to the Neonatal Intensive Care Unit (NICU)
Neonatal Length of Stay in NICU
Neonatal Length of Hospital Stay
Number of Neonatal Deaths
Number of Neonates With Intraventricular Hemorrhage Diagnosed Using Cranial Ultrasonography
Number of Neonates With Necrotizing Enterocolitis
Number of Neonates With Culture-positive Sepsis
Number of Neonates With Seizures
Number of Neonates Who Needed Mechanical Ventilation
Neonatal Duration of Ventilator Use
Number of Neonates Who Received Continuous Positive Airway Pressure (CPAP)
Number of Maternal Participants Who Delivered by Cesarean Delivery
Number of Maternal Participants Who Had Clinical Chorioamnionitis
Number of Maternal Participants Who Had Preterm Premature Rupture of Membranes (PPROM)
Number of Maternal Participants Who Had Preeclampsia
Number of Maternal Participants Who Needed Blood Transfusion
Number of Maternal Participants With Headache
Number of Maternal Participants With Nausea
Number of Maternal Participants With Vomiting
Number of Maternal Participants With Acid Reflux
Number of Maternal Participants With Hypotension
Number of Maternal Participants With Tachycardia
Number of Maternal Participants With Syncope
Full Information
NCT ID
NCT02438371
First Posted
May 5, 2015
Last Updated
October 25, 2021
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT02438371
Brief Title
Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor
Official Title
Nifedipine Alone or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor: An Open Label, Randomized Comparative Effectiveness Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Study halted due to slow recruitment
Study Start Date
May 2015 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
Keywords
pregnancy, preterm labor, tocolysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nifedipine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nifedipine plus Indomethacin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Other Intervention Name(s)
Procardia
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Primary Outcome Measure Information:
Title
Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation
Time Frame
48 hours after administration of tocolytic agent
Secondary Outcome Measure Information:
Title
Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation
Time Frame
7 days after administration of tocolytic agent
Title
Number of Days From First Dose of Tocolytic Agent to Delivery
Description
Length of time from tocolytic initiation to the time of delivery
Time Frame
from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Title
Neonatal Birthweight
Time Frame
at the time of birth
Title
Neonatal Sex
Time Frame
at the time of birth
Title
Number of Neonates Who Were Admitted to the Neonatal Intensive Care Unit (NICU)
Time Frame
from birth until hospital discharge or day 120 of life (whichever occurs first)
Title
Neonatal Length of Stay in NICU
Time Frame
from birth until hospital discharge or day 120 of life (whichever occurs first)
Title
Neonatal Length of Hospital Stay
Time Frame
from birth until hospital discharge or day 120 of life (whichever occurs first)
Title
Number of Neonatal Deaths
Time Frame
from birth until hospital discharge or day 120 of life (whichever occurs first)
Title
Number of Neonates With Intraventricular Hemorrhage Diagnosed Using Cranial Ultrasonography
Time Frame
from birth until hospital discharge or day 120 of life (whichever occurs first)
Title
Number of Neonates With Necrotizing Enterocolitis
Time Frame
from birth until hospital discharge or day 120 of life (whichever occurs first)
Title
Number of Neonates With Culture-positive Sepsis
Time Frame
from birth until hospital discharge or day 120 of life (whichever occurs first)
Title
Number of Neonates With Seizures
Time Frame
from birth until hospital discharge or day 120 of life (whichever occurs first)
Title
Number of Neonates Who Needed Mechanical Ventilation
Time Frame
from birth until hospital discharge or day 120 of life (whichever occurs first)
Title
Neonatal Duration of Ventilator Use
Time Frame
from birth until hospital discharge or day 120 of life (whichever occurs first)
Title
Number of Neonates Who Received Continuous Positive Airway Pressure (CPAP)
Time Frame
from birth until hospital discharge or day 120 of life (whichever occurs first)
Title
Number of Maternal Participants Who Delivered by Cesarean Delivery
Time Frame
at the the time of birth
Title
Number of Maternal Participants Who Had Clinical Chorioamnionitis
Time Frame
from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Title
Number of Maternal Participants Who Had Preterm Premature Rupture of Membranes (PPROM)
Time Frame
from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Title
Number of Maternal Participants Who Had Preeclampsia
Time Frame
from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Title
Number of Maternal Participants Who Needed Blood Transfusion
Time Frame
from time of birth to time of discharge from hospital (about 2-3 days)
Title
Number of Maternal Participants With Headache
Time Frame
from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Title
Number of Maternal Participants With Nausea
Time Frame
from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Title
Number of Maternal Participants With Vomiting
Time Frame
from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Title
Number of Maternal Participants With Acid Reflux
Time Frame
from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Title
Number of Maternal Participants With Hypotension
Time Frame
from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Title
Number of Maternal Participants With Tachycardia
Time Frame
from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Title
Number of Maternal Participants With Syncope
Time Frame
from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Hutchinson, M.S.
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Study Director
Facility Information:
Facility Name
Memorial Hermann Hospital Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35947046
Citation
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.
Results Reference
derived
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Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor
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