Tocolysis for Preterm Labor

NCT00811057 | Completed Results

• 1 other identifier: 2003-0249
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11% of all pregnancies and it is responsible for 70% of sick babies. The ideal way to stop preterm labor when it occurs (which drug to use) is not known. Currently magnesium sulfate is used by about 95% of all practitioners, but recent data suggest magnesium given this way may be harmful for the baby's future development. Other drugs such as antiprostaglandin agents are very effective in stopping uterine activity, but particularly when used for \>48 hours have been associated with both maternal and fetal sides effects. Lastly, calcium channel antagonists are effective in stopping contractions and have very little in the way of maternal and fetal side effects, but less data is available in the United States on their use. Because there is no FDA approved drug to stop preterm labor, we purpose to randomize all women with preterm labor (20-34 weeks) to receive one of the above three methods of stopping preterm labor. The primary outcomes will be to see which agent stops the uterine contractions most effectively, for the longest period of time with fewest relapses and results in significant prolongation of pregnancy. If one of these agents is clearly superior to the other two it would help women avoid early delivery or have significant extension of their pregnancy to avoid some of the complications of preterm birth in the baby.

Conditions

Preterm Labor

Keywords

Preterm Labor in Pregnancy

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Measure of This Research is to Compare the Efficacy of the Three Clinically Used Tocolytic Agents in a Prospective Study That Will Allow Direct Comparison of Outcomes in Women With Confirmed Preterm Labor.

  Gestational age at delivery in weeks.

  3-5 days after delivery

Secondary Outcomes (1)

• The Secondary Outcome Measure of This Research is the Days Gained After Treatment to Delivery

  after delivery of the infant

Study Arms (3)

1 Magnesium Sulfate

ACTIVE COMPARATOR

Drug: 1 Magnesium Sulfate

2 Nifedipine

ACTIVE COMPARATOR

Participants randomized to this group will receive the medication nifedipine orally.

Drug: Nifedipine

3 Indomethacin

ACTIVE COMPARATOR

Participants randomized to this arm will receive the medication indomethacin per rectum and orally.

Drug: Indomethacin

Interventions

1 Magnesium Sulfate DRUG

Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.

1 Magnesium Sulfate

Nifedipine DRUG

Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved.

2 Nifedipine

Indomethacin DRUG

Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved.

3 Indomethacin

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnancies with intact membranes in confirmed preterm labor;
• weeks' gestation;
• Cervical dilatation 0 - 3cm versus 4 - 6cm;
• No conditions contraindicating continued pregnancy (severe IUGR, chorioamnionitis, non-reassuring fetal tracing - physician judgement); AND
• Able and willing to consent to the study protocol.

You may not qualify if:

• Failure to meet admission criteria;
• Known serious fetal malformations;
• Severe maternal/obstetric disease affecting the mother or fetus (severe cardiac disease, placental abruption/previa, severe diabetes, severe preeclampsia, etc. - physician judgment);
• Allergic to magnesium, antiprostaglandin or calcium channel antagonist;
• Refusal or inability to consent to the study

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

The Winfred L. Wiser Hospital for Women and Infants at the University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (1)

• 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.

  PMID: 35947046 DERIVED

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Nifedipine; Indomethacin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Rick Martin
• Organization: University of Mississippi Medical Center

rmartin@umc.edu

601-815-7035

Study Officials

• Rick W Martin, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Maternal-Fetal Medicine; Dept of Ob-Gyn

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 18, 2008
• Study Start: June 1, 2004
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2010
• Last Updated: April 4, 2013
• Results First Posted: April 4, 2013

Record last verified: 2013-02

Locations

US (1)