Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

The University of Texas System (UT)

Status and phase: Terminated; Phase 4

Conditions: Preterm Labor

Treatments: Drug: Nifedipine; Drug: Indomethacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02438371

HSC-MS-15-0134

Details and patient eligibility

About

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

Full 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

Enrollment: 49 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Nifedipine

Active Comparator group

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.

Treatment:

Drug: Nifedipine

Nifedipine plus Indomethacin

Active Comparator group

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.

Treatment:

Drug: Indomethacin

Drug: Nifedipine