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Preterm LaborEarly Phase 1NCT01869361

Indomethacin for Tocolysis of Preterm Labor

A Early Phase 1 study testing Indomethacin in people with Preterm Labor, run by MetroHealth Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Indomethacin for tocolysis for 48 hours vs placebo Read more about this study

Who is it for?
Ages 16 to 50 years, women only
Conditions the study is for
Preterm Labor
What is being tested?
Indomethacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Aug 2020to 23 Nov 2021
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 50 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Preterm labor as defined by regular uterine contractions (at least 6/hour) with cervical change of at least 1 cm or cervical shortening on transvaginal ultrasound less than 25mm of functional length
  • Gestational age 23w0d to 31w6d weeks
  • Singleton
  • ≥ 18 years old
  • Able to consent in English

Who cannot join

  • Major congenital anomalies associated with an increased risk of newborn death
  • Multiple fetal gestation (2+)
  • Known intrauterine fetal demise
  • Non-reassuring fetal status requiring delivery
  • Preterm premature rupture of membranes (PPROM)
  • Suspected or known intrauterine infection
Show all 9Show fewer
  • Placenta previa
  • Maternal allergy or contraindication to indomethacin (peptic ulcer disease, thrombocytopenia, coagulopathy, renal or hepatic dysfunction)
  • Inevitable delivery (cervix ≥6cm dilated)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

Other trials in United States

About this study

Official title: Randomized, Placebo Controlled Trial of Indomethacin for Tocolysis

Indomethacin for tocolysis for 48 hours vs placebo

Read the detailed description

Background: Indomethacin is frequently used as a tocolytic, however there is currently only scant evidence to support its efficacy.

Goals: To delay preterm delivery by 48 hours and to examine longer latency periods and maternal and neonatal outcomes Methods: Randomized placebo-controlled trial of indomethacin for tocolysis. Women with a singleton pregnancy between 23w0d and 31w6d in preterm labor randomly assigned to 50mg indomethacin by mouth followed by 25mg by mouth every 6hour for 48 hours or placebo. Patients receive betamethasone for fetal lung maturity, if not previously administered, and magnesium sulfate for neuroprotection. Ultrasound performed before initiation of study drug and after completion of study medication for amniotic fluid index and fetal cardiac assessment.

Conditions
Preterm Labor
Being tested
Indomethacin, Placebo
Keywords
preterm labor, tocolysis, indomethacin
Medical subject headings
Obstetric Labor, Premature

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IndomethacinDrug

    Also called Indocin

    Study drug

  • PlaceboDrug

    Control drug

Study groups in NCT01869361
Study groupRoleWhat they receive
PlaceboPlacebo comparatorThe patient will be given a loading dose of 50mg placebo by mouth followed by 25mg by mouth every six hours for a total of eight doses over 48 hours.
Receives: Drug: Placebo
IndomethacinActive comparatorThe patient will be given a loading dose of 50mg indomethacin by mouth followed by 25mg by mouth every six hours for a total of eight doses over 48 hours.
Receives: Drug: Indomethacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. delivery within 48 hours

    The percentage of patients remaining undelivered after 48 hours

    Measured: 48 hours after enrollment

Secondary outcomes (3)

  1. delivery within 7 days

    The percentage of patients remaining undelivered after 7 days

    Measured: 7 days after enrollment

  2. delivery before 37 weeks

    The percentage of patients remaining undelivered until 37 weeks gestational age

    Measured: participants will be followed for the duration of pregnancy through their postpartum period, an expected time of up to 20 weeks

  3. Maternal and Fetal Complications

    composite of maternal intolerance of the drug, birth weight, gestational age, neonatal morbidities, changes in amniotic fluid volume, fetal cardiac assessment, or premature constriction of the ductus arteriosus.

    Measured: participants will be followed for the duration of pregnancy through their postpartum period and neonatal hospital stay, an expected time of up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2013 (estimated)
  2. Study start1 Aug 2020
  3. Primary completion23 Nov 2021
  4. Study completion23 Nov 2021

Why it stopped: Due to much lower than expected numbers of eligible patients and lack of PI time, the study was not started.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01869361
Sponsor's protocol ID
IRB13-00533
Status last verified
Nov 2021
First submitted
29 May 2013
Last updated
7 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • American College of Obstetricians and Gynecologists; Committee on Practice Bulletins-Obstetrics. ACOG practice bulletin no. 127: Management of preterm labor. Obstet Gynecol. 2012 Jun;119(6):1308-17. doi: 10.1097/AOG.0b013e31825af2f0.

    PubMed 22617615

  • Haas DM, Caldwell DM, Kirkpatrick P, McIntosh JJ, Welton NJ. Tocolytic therapy for preterm delivery: systematic review and network meta-analysis. BMJ. 2012 Oct 9;345:e6226. doi: 10.1136/bmj.e6226.

    PubMed 23048010

  • Hayes E, Moroz L, Pizzi L, Baxter J. A cost decision analysis of 4 tocolytic drugs. Am J Obstet Gynecol. 2007 Oct;197(4):383.e1-6. doi: 10.1016/j.ajog.2007.06.052.

    PubMed 17904969

  • Abramovici A, Cantu J, Jenkins SM. Tocolytic therapy for acute preterm labor. Obstet Gynecol Clin North Am. 2012 Mar;39(1):77-87. doi: 10.1016/j.ogc.2011.12.003. Epub 2012 Jan 4.

    PubMed 22370109

  • 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.

    PubMed 6374098

  • 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.

    PubMed 7369252

  • Panter KR, Hannah ME, Amankwah KS, Ohlsson A, Jefferies AL, Farine D. The effect of indomethacin tocolysis in preterm labour on perinatal outcome: a randomised placebo-controlled trial. Br J Obstet Gynaecol. 1999 May;106(5):467-73. doi: 10.1111/j.1471-0528.1999.tb08300.x.

    PubMed 10430197

  • Amin SB, Sinkin RA, Glantz JC. Metaanalysis of the effect of antenatal indomethacin on neonatal outcomes. Am J Obstet Gynecol. 2007 Nov;197(5):486.e1-10. doi: 10.1016/j.ajog.2007.04.019.

    PubMed 17980183

  • Sood BG, Lulic-Botica M, Holzhausen KA, Pruder S, Kellogg H, Salari V, Thomas R. The risk of necrotizing enterocolitis after indomethacin tocolysis. Pediatrics. 2011 Jul;128(1):e54-62. doi: 10.1542/peds.2011-0265. Epub 2011 Jun 20.

    PubMed 21690109

  • Loe SM, Sanchez-Ramos L, Kaunitz AM. Assessing the neonatal safety of indomethacin tocolysis: a systematic review with meta-analysis. Obstet Gynecol. 2005 Jul;106(1):173-9. doi: 10.1097/01.AOG.0000168622.56478.df.

    PubMed 15994634

  • Cordero L, Nankervis CA, Gardner D, Giannone PJ. The effects of indomethacin tocolysis on the postnatal response of the ductus arteriosus to indomethacin in extremely low birth weight infants. J Perinatol. 2007 Jan;27(1):22-7. doi: 10.1038/sj.jp.7211612. Epub 2006 Oct 19.

    PubMed 17053778

  • Eronen M, Pesonen E, Kurki T, Ylikorkala O, Hallman M. The effects of indomethacin and a beta-sympathomimetic agent on the fetal ductus arteriosus during treatment of premature labor: a randomized double-blind study. Am J Obstet Gynecol. 1991 Jan;164(1 Pt 1):141-6. doi: 10.1016/0002-9378(91)90644-7.

    PubMed 1986601

  • 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.

    PubMed 35947046

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Indomethacin in people with Preterm Labor, run by MetroHealth Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

delivery within 48 hours (time frame: 48 hours after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01869361, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.

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