Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Indomethacin and Nifedipine are commonly used medications for treatment of pre term labor. This study will compare the efficacy and adverse outcomes of oral nifedipine versus oral indomethacin for preterm labor tocolysis in an effort to identify which drug is most effective.
Patients diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used.
Patients presenting between 24-34 weeks gestation diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used. Antibiotics and steroids for fetal lung maturity will be administered as per standard of care for preterm labor. Maternal side effects and delivery outcomes will be assessed from questionnaires administered by the study team following treatment, and/or from review of the patient's medical records.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indomethacin | Active Comparator | 50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs. |
|
| Nifedipine | Active Comparator | 30 mg Nifedipine initially followed by 20 mg every 6 hrs for 48 hrs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin | Drug | One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization | Preterm labor was defined as documented cervical change and regular uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% cervical effacement. Preterm labor is defined as uterine contractions occurring up to 37 weeks of pregnancy. | Two weeks after enrolled and randomized, up to 37 weeks of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Birthweight | Birthweight is presented in grams | Until discharge of mother and neonate from delivery hospital, up to 30 days after delivery |
| Gestational Age at Delivery | Up to 42 weeks of pregnancy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deirdre Judith Lyell | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35947046 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 29 patients were initially consented and enrolled. Patients were enrolled through December 2012 but protocol remained open until 2018. Due to patient privacy regulations, the data were accessible for only 10 patients.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Indomethacin | 50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs. Indomethacin: One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs. |
| FG001 | Nifedipine | 30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs. Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data were accessible for limited participants due to patient privacy regulations.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Indomethacin | 50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs. Indomethacin: One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs. |
| BG001 | Nifedipine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization | Preterm labor was defined as documented cervical change and regular uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% cervical effacement. Preterm labor is defined as uterine contractions occurring up to 37 weeks of pregnancy. | Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations. | Posted | Count of Participants | Participants | Two weeks after enrolled and randomized, up to 37 weeks of pregnancy |
|
Up to maternal and neonatal discharge from the delivery hospital, up to 30 days after the delivery.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Indomethacin | 50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs. Indomethacin: One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal symptoms | Gastrointestinal disorders | Non-systematic Assessment |
The sample size for the analysis was not reached.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deirdre Lyell | Stanford University | 6507255720 | dlyell@stanford.edu |
Not provided
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nifedipine | Drug | Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs. |
|
| Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery | Up to 42 weeks of pregnancy |
| Count of Participants With Neonatal Morbidity | Neonatal morbidity included admission to neonatal intensive care unit, respiratory distress or sepsis. | Up to 42 weeks of pregnancy |
| Count of Participants With Side-effect Due to the Medication | Monitored side-effects for this outcome included abdominal pain, blood pressure change, GI-symptoms and skin rash. | Up to 42 weeks of pregnancy |
| Time to Uterine Quiescence | Uterine quiescence was defined as six or fewer uterine contractions per hour. Outcome was described as days. | Up to 42 weeks of pregnancy |
30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs. Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Nifedipine | 30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs. Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs. |
|
|
|
| Secondary | Neonatal Birthweight | Birthweight is presented in grams | Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations. | Posted | Median | Inter-Quartile Range | grams | Until discharge of mother and neonate from delivery hospital, up to 30 days after delivery |
|
|
|
| Secondary | Gestational Age at Delivery | Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations. | Posted | Median | Inter-Quartile Range | weeks | Up to 42 weeks of pregnancy |
|
|
|
| Secondary | Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery | Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations. | Posted | Median | Inter-Quartile Range | days | Up to 42 weeks of pregnancy |
|
|
|
| Secondary | Count of Participants With Neonatal Morbidity | Neonatal morbidity included admission to neonatal intensive care unit, respiratory distress or sepsis. | Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations. | Posted | Count of Participants | Participants | Up to 42 weeks of pregnancy |
|
|
|
| Secondary | Count of Participants With Side-effect Due to the Medication | Monitored side-effects for this outcome included abdominal pain, blood pressure change, GI-symptoms and skin rash. | Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations. | Posted | Count of Participants | Participants | Up to 42 weeks of pregnancy |
|
|
|
| Secondary | Time to Uterine Quiescence | Uterine quiescence was defined as six or fewer uterine contractions per hour. Outcome was described as days. | Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations. | Posted | Median | Inter-Quartile Range | days | Up to 42 weeks of pregnancy |
|
|
|
| 0 |
| 5 |
| 2 |
| 5 |
| EG001 | Nifedipine | 30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs. Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs. | 0 | 5 | 3 | 5 |
| Hypotension | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |