Study Results
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Basic Information
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UNKNOWN
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2020-10-31
2025-04-30
Brief Summary
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Nifedipine is a calcium channel blocker agent that has been shown to reduce rates of labor within 48 hours from treatment.
Previous studies comparing rectal Indometacin to oral nifedipine were inconclusive.
Prostaglandins are synthesized in the uterus and the uterine cervix and therefore local administration of Indometacin may be more effective than other forms of administration, as been shown in a previous study.
In this study we aim to compare vaginal Indometacin administration to a commonly used tocolytic agent, nifedipine.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Indomethacin group
Group of patients receiving Indomethacin for preterm labor treatment.
Indomethacin
Per vagina administration of 100 mg followed by a second 100 mg dosage the following day
Nifedipine group
Group of patients receiving Nifedipine for preterm labor treatment.
Nifedipine
Per os administration according to current protocol of 20mg each 20 minutes for 1 hour followed by 20 mg q8 for 48 hours.
Interventions
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Indomethacin
Per vagina administration of 100 mg followed by a second 100 mg dosage the following day
Nifedipine
Per os administration according to current protocol of 20mg each 20 minutes for 1 hour followed by 20 mg q8 for 48 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gestational age between 24+0/7 and 31+6/7
* At least one uterine contraction in ten minutes for at least 20 minutes upon tocography admission
* Cervical parameters: 1 cm dilation or more or 80% cervical effacement or cervical length 20mm or less
Exclusion Criteria
* Vaginal bleeding
* Cervical dilation ≥5cm
* Known fetal malformations
* Fetal heart rate abnormalities
* Suspected placental abruption of adherent placental syndrome
* Known sensitivity to one of the drugs used in the study (Indometacin and nifedipine)
* Maternal hypotension and known aortic or mitral stenosis
* Presence of cervical cerclage
* Previous administration of tocolytic drugs in current pregnancy
16 Years
60 Years
FEMALE
Yes
Sponsors
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Sheba Medical Center
OTHER_GOV
Soroka University Medical Center
OTHER
Hadassah Medical Organization
OTHER
Responsible Party
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Hila Hocler MD
Principal Investigator
Principal Investigators
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Hila Hochler, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Central Contacts
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References
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Niebyl JR, Blake DA, White RD, Kumor KM, Dubin NH, Robinson JC, Egner PG. The inhibition of premature labor with indomethacin. Am J Obstet Gynecol. 1980 Apr 15;136(8):1014-9. doi: 10.1016/0002-9378(80)90629-8.
Zuckerman H, Shalev E, Gilad G, Katzuni E. Further study of the inhibition of premature labor by indomethacin. Part II double-blind study. J Perinat Med. 1984;12(1):25-9. doi: 10.1515/jpme.1984.12.1.25.
Besinger RE, Niebyl JR, Keyes WG, Johnson TR. Randomized comparative trial of indomethacin and ritodrine for the long-term treatment of preterm labor. Am J Obstet Gynecol. 1991 Apr;164(4):981-6; discussion 986-8. doi: 10.1016/0002-9378(91)90569-d.
Haas DM, Imperiale TF, Kirkpatrick PR, Klein RW, Zollinger TW, Golichowski AM. Tocolytic therapy: a meta-analysis and decision analysis. Obstet Gynecol. 2009 Mar;113(3):585-594. doi: 10.1097/AOG.0b013e318199924a.
O'Brien WF. The role of prostaglandins in labor and delivery. Clin Perinatol. 1995 Dec;22(4):973-84.
Bry K, Hallman M. Prostaglandins, inflammation, and preterm labor. J Perinatol. 1989 Mar;9(1):60-5.
Abramov Y, Nadjari M, Weinstein D, Ben-Shachar I, Plotkin V, Ezra Y. Indomethacin for preterm labor: a randomized comparison of vaginal and rectal-oral routes. Obstet Gynecol. 2000 Apr;95(4):482-6. doi: 10.1016/s0029-7844(99)00578-5.
Flenady V, Wojcieszek AM, Papatsonis DN, Stock OM, Murray L, Jardine LA, Carbonne B. Calcium channel blockers for inhibiting preterm labour and birth. Cochrane Database Syst Rev. 2014 Jun 5;2014(6):CD002255. doi: 10.1002/14651858.CD002255.pub2.
Reinebrant HE, Pileggi-Castro C, Romero CL, Dos Santos RA, Kumar S, Souza JP, Flenady V. Cyclo-oxygenase (COX) inhibitors for treating preterm labour. Cochrane Database Syst Rev. 2015 Jun 5;2015(6):CD001992. doi: 10.1002/14651858.CD001992.pub3.
Kashanian M, Bahasadri S, Zolali B. Comparison of the efficacy and adverse effects of nifedipine and indomethacin for the treatment of preterm labor. Int J Gynaecol Obstet. 2011 Jun;113(3):192-5. doi: 10.1016/j.ijgo.2010.12.019. Epub 2011 Apr 1.
Klauser CK, Briery CM, Keiser SD, Martin RW, Kosek MA, Morrison JC. Effect of antenatal tocolysis on neonatal outcomes. J Matern Fetal Neonatal Med. 2012 Dec;25(12):2778-81. doi: 10.3109/14767058.2012.714819. Epub 2012 Aug 20.
Klauser CK, Briery CM, Martin RW, Langston L, Magann EF, Morrison JC. A comparison of three tocolytics for preterm labor: a randomized clinical trial. J Matern Fetal Neonatal Med. 2014 May;27(8):801-6. doi: 10.3109/14767058.2013.847416. Epub 2013 Oct 11.
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.
Other Identifiers
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TOCOMED-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id
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