Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

Preterm Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02438371
• Other study ID #: HSC-MS-15-0134
• Status: Terminated
• Phase: Phase 4
• Start date: May 2015
• Est. completion date: October 10, 2019

Study information

• Verified date: October 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Drug:
• Nifedipine

• Indomethacin

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital Texas Medical Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation		48 hours after administration of tocolytic agent
Secondary	Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation		7 days after administration of tocolytic agent
Secondary	Number of Days From First Dose of Tocolytic Agent to Delivery	Length of time from tocolytic initiation to the time of delivery	from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Secondary	Neonatal Birthweight		at the time of birth
Secondary	Neonatal Sex		at the time of birth
Secondary	Number of Neonates Who Were Admitted to the Neonatal Intensive Care Unit (NICU)		from birth until hospital discharge or day 120 of life (whichever occurs first)
Secondary	Neonatal Length of Stay in NICU		from birth until hospital discharge or day 120 of life (whichever occurs first)
Secondary	Neonatal Length of Hospital Stay		from birth until hospital discharge or day 120 of life (whichever occurs first)
Secondary	Number of Neonatal Deaths		from birth until hospital discharge or day 120 of life (whichever occurs first)
Secondary	Number of Neonates With Intraventricular Hemorrhage Diagnosed Using Cranial Ultrasonography		from birth until hospital discharge or day 120 of life (whichever occurs first)
Secondary	Number of Neonates With Necrotizing Enterocolitis		from birth until hospital discharge or day 120 of life (whichever occurs first)
Secondary	Number of Neonates With Culture-positive Sepsis		from birth until hospital discharge or day 120 of life (whichever occurs first)
Secondary	Number of Neonates With Seizures		from birth until hospital discharge or day 120 of life (whichever occurs first)
Secondary	Number of Neonates Who Needed Mechanical Ventilation		from birth until hospital discharge or day 120 of life (whichever occurs first)
Secondary	Neonatal Duration of Ventilator Use		from birth until hospital discharge or day 120 of life (whichever occurs first)
Secondary	Number of Neonates Who Received Continuous Positive Airway Pressure (CPAP)		from birth until hospital discharge or day 120 of life (whichever occurs first)
Secondary	Number of Maternal Participants Who Delivered by Cesarean Delivery		at the the time of birth
Secondary	Number of Maternal Participants Who Had Clinical Chorioamnionitis		from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Secondary	Number of Maternal Participants Who Had Preterm Premature Rupture of Membranes (PPROM)		from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Secondary	Number of Maternal Participants Who Had Preeclampsia		from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Secondary	Number of Maternal Participants Who Needed Blood Transfusion		from time of birth to time of discharge from hospital (about 2-3 days)
Secondary	Number of Maternal Participants With Headache		from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Secondary	Number of Maternal Participants With Nausea		from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Secondary	Number of Maternal Participants With Vomiting		from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Secondary	Number of Maternal Participants With Acid Reflux		from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Secondary	Number of Maternal Participants With Hypotension		from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Secondary	Number of Maternal Participants With Tachycardia		from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Secondary	Number of Maternal Participants With Syncope		from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)