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Obstetric Labor, PrematurePhase 2/3TOCOMEDNCT04404686

Vaginal Indomethacin for Preterm Labor

A Phase 2/3 study testing Indomethacin and Nifedipine in people with Obstetric Labor, Premature, run by Hadassah Medical Organization.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Indometacin is a cyclooxygenase agent from the NSAID family that has been used to treat preterm contractions since the 70's by preventing the synthesis of prostaglandins. It has been shown to be significantly more effective than placebo and postpone labor for 7-10 days, prolong pregnancies above 37 weeks of gestation… Read more about this study

Who is it for?
Ages 16 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obstetric Labor, Premature
What is being tested?
Indomethacin and Nifedipine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
No sites listed yet
Study dates
Oct 2020to Apr 2025
Phase
Phase 2/3
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 60 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Singe fetus
  • 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

Who cannot join

  • Rupture of membranes
  • Vaginal bleeding
  • Cervical dilation ≥5cm
  • Known fetal malformations
  • Fetal heart rate abnormalities
  • Suspected placental abruption of adherent placental syndrome
Show all 10Show fewer
  • 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

Trial locations and contacts

No sites are listed yet.

Hila Hochler, MD contact

00 972 52 300 3722

hilahochler@gmail.com

Hadas Lemberg, PhD contact

00 972 2 6777572

lhadas@hadassah.org.il

About this study

Official title: Vaginal Indomethacin Versus Oral Nifedipine for Preterm Labor; a Randomized Controlled Trial

Indometacin is a cyclooxygenase agent from the NSAID family that has been used to treat preterm contractions since the 70's by preventing the synthesis of prostaglandins. It has been shown to be significantly more effective than placebo and postpone labor for 7-10 days, prolong pregnancies above 37 weeks of gestation and reduce numbers of small for gestational age neonates.

Nifedipine is a calcium channel blocker agent that has been shown to reduce rates of labor within 48 hours from treatment.

Read more

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.

Being tested
Indomethacin, Nifedipine
Keywords
preterm labor, tocolysis, prematurity
Medical subject headings
Obstetric Labor, Premature, Premature Birth

What participants receive

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

  • IndomethacinDrug

    Also called Indomed

    Per vagina administration of 100 mg followed by a second 100 mg dosage the following day

  • NifedipineDrug

    Also called Pressolat

    Per os administration according to current protocol of 20mg each 20 minutes for 1 hour followed by 20 mg q8 for 48 hours.

Study groups in NCT04404686
Study groupRoleWhat they receive
Indomethacin groupExperimentalGroup of patients receiving Indomethacin for preterm labor treatment.
Receives: Drug: Indomethacin
Nifedipine groupActive comparatorGroup of patients receiving Nifedipine for preterm labor treatment.
Receives: Drug: Nifedipine

What is being measured

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

  1. Time to delivery

    The time from administration of intervention do delivery

    Measured: through study completion, approximately 1 year

  2. Gestational age

    Days from last menstrual period

    Measured: through study completion, approximately 1 year

Secondary outcomes (7)

  1. Rate of preterm deliveries

    Rate of deliveries under 37+0/7 weeks of gestation

    Measured: through study completion, approximately 1 year

  2. Rate of remote from term deliveries

    Rate of deliveries under 34+0/7 weeks of gestation

    Measured: through study completion, approximately 1 year

  3. Rate of extreme preterm deliveries

    Rate of deliveries under 28+0/7 weeks of gestation

    Measured: through study completion, approximately 1 year

  4. neonatal immediate outcomes

    Neonatal Apgar scores

    Measured: through study completion, approximately 1 year

  5. Neonatal immediate outcome

    Neonatal umbilical cord pH levels

    Measured: through study completion, approximately 1 year

  6. Neonatal birth weight

    birth wight as recorded in chart in grams

    Measured: through study completion, approximately 1 year

  7. Neonatal outcomes

    neonatal intensive care unit administration rate

    Measured: through study completion, approximately 1 year

Timeline

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

  1. First posted27 May 2020
  2. Study startOct 2020 (estimated)
  3. Primary completionApr 2024 (estimated)
  4. Study completionApr 2025 (estimated)

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
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04404686
Sponsor's protocol ID
TOCOMED-HMO-CTIL
Acronym
TOCOMED
Status last verified
Aug 2020
First submitted
7 May 2020
Last updated
11 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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

  • 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.

    PubMed 2014850

  • 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.

    PubMed 19300321

  • O'Brien WF. The role of prostaglandins in labor and delivery. Clin Perinatol. 1995 Dec;22(4):973-84.

    PubMed 8665768

  • Bry K, Hallman M. Prostaglandins, inflammation, and preterm labor. J Perinatol. 1989 Mar;9(1):60-5.

    PubMed 2496208

  • 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.

    PubMed 10725476

  • 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.

    PubMed 24901312

  • 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.

    PubMed 26042617

  • 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.

    PubMed 21457979

  • 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.

    PubMed 22873356

  • 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.

    PubMed 24090282

  • 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 Phase 2/3 study testing Indomethacin and Nifedipine in people with Obstetric Labor, Premature, run by Hadassah Medical Organization.

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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Hila Hochler, MD (00 972 52 300 3722, hilahochler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to delivery (time frame: through study completion, approximately 1 year). The study lists 2 primary outcomes in all. 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 NCT04404686, 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 11 Aug 2020.

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