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Preterm LaborNCT03202836

Vaginal Progesterone Supplementation in the Management of Preterm Labor

A study testing progesterone, Tocolytics and Steroids in people with Preterm Labor, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the addition of vaginal progesterone in the management of preterm labor. Half of participants will receive vaginal progesterone, tocolysis and corticosteroid, while the other half will receive only tocolysis and corticosteroid. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Preterm Labor
What is being tested?
progesterone, Tocolytics and Steroids
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteThailand
Study dates
29 Jun 2017to 31 Jul 2018
Phase
Interventional
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 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • singleton pregnant women with preterm labor, gestational age 24-34 weeks

Who cannot join

  • have indicated preterm birth
  • allergy to progesterone
  • fetal anomalies
  • cervical dilate > 5 cm.
  • have medical disease
  • have obstetric complication

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Medicine, Chulalongkorn University

    Bangkok, 10330

Other trials in Thailand

About this study

Official title: Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized, Double Blind, Controlled Trial

This study evaluates the addition of vaginal progesterone in the management of preterm labor. Half of participants will receive vaginal progesterone, tocolysis and corticosteroid, while the other half will receive only tocolysis and corticosteroid.

Conditions
Preterm Labor
Being tested
progesterone, Tocolytics, Steroids
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.

  • progesteroneDrug

    Also called utrogestan

    vaginal utrogestan

  • TocolyticsDrug

    tocolysis for 48 hours

  • SteroidsDrug

    antenatal corticosteroids for 48 hours

Study groups in NCT03202836
Study groupRoleWhat they receive
vaginal progesteroneExperimentalVaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours
Receives: Drug: progesterone; Drug: Tocolytics; Drug: Steroids
no medicationOtheronly tocolysis plus corticosteroid for 48 hours
Receives: Drug: Tocolytics; Drug: Steroids

What is being measured

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

  1. Time from preterm labor pain to delivery

    time since preterm labor to delivery

    Measured: 9 weeks

Secondary outcomes (7)

  1. gestational age at delivery

    gestational age at birth

    Measured: 9 weeks

  2. number of pregnant women deliver before 34 weeks

    preterm birth < 34 weeks

    Measured: 6 weeks

  3. number of pregnant women deliver before 37 weeks

    preterm birth < 37 weeks

    Measured: 9 weeks

  4. Number of newborn with respiratory distress syndrome

    Number of newborn with respiratory distress syndrome

    Measured: 9 weeks

  5. Number of newborn with intraventricular hemorrhage

    Number of newborn with intraventricular hemorrhage

    Measured: 9 weeks

  6. Number of newborn with necrotizing enterocolitis

    Number of newborn with necrotizing enterocolitis

    Measured: 9 weeks

  7. Number of newborn with sepsis

    Number of newborn with sepsis

    Measured: 9 weeks

Timeline

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

  1. First posted29 Jun 2017
  2. Study start29 Jun 2017
  3. Primary completion30 Jul 2018
  4. Study completion31 Jul 2018

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03202836
Sponsor's protocol ID
230/2017
Status last verified
Jan 2019
First submitted
24 Jun 2017
Last updated
31 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • O'Brien JM. Vaginal progesterone prophylaxis for preterm birth. Lancet. 2016 Sep 17;388(10050):1159-60. doi: 10.1016/S0140-6736(16)31614-2. Epub 2016 Sep 16. No abstract available.

    PubMed 27650091

  • Azargoon A, Ghorbani R, Aslebahar F. Vaginal progesterone on the prevention of preterm birth and neonatal complications in high risk women: A randomized placebo-controlled double-blind study. Int J Reprod Biomed. 2016 May;14(5):309-16.

    PubMed 27326415

  • Elimian A, Smith K, Williams M, Knudtson E, Goodman JR, Escobedo MB. A randomized controlled trial of intramuscular versus vaginal progesterone for the prevention of recurrent preterm birth. Int J Gynaecol Obstet. 2016 Aug;134(2):169-72. doi: 10.1016/j.ijgo.2016.01.010. Epub 2016 Apr 18.

    PubMed 27168167

  • Conde-Agudelo A, Romero R. Vaginal progesterone to prevent preterm birth in pregnant women with a sonographic short cervix: clinical and public health implications. Am J Obstet Gynecol. 2016 Feb;214(2):235-242. doi: 10.1016/j.ajog.2015.09.102. Epub 2015 Oct 9.

    PubMed 26450404

  • Romero R. Vaginal progesterone to reduce the rate of preterm birth and neonatal morbidity: a solution at last. Womens Health (Lond). 2011 Sep;7(5):501-4. doi: 10.2217/whe.11.60. No abstract available.

    PubMed 21879816

  • Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW; PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15.

    PubMed 21472815

  • da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol. 2003 Feb;188(2):419-24. doi: 10.1067/mob.2003.41.

    PubMed 12592250

  • Palacio M, Cobo T, Antolin E, Ramirez M, Cabrera F, Mozo de Rosales F, Bartha JL, Juan M, Marti A, Oros D, Rodriguez A, Scazzocchio E, Olivares JM, Varea S, Rios J, Gratacos E; PROMISE Collaborative Group. Vaginal progesterone as maintenance treatment after an episode of preterm labour (PROMISE) study: a multicentre, double-blind, randomised, placebo-controlled trial. BJOG. 2016 Nov;123(12):1990-1999. doi: 10.1111/1471-0528.13956. Epub 2016 Mar 30.

    PubMed 27028759

  • Martinez de Tejada B, Karolinski A, Ocampo MC, Laterra C, Hosli I, Fernandez D, Surbek D, Huespe M, Drack G, Bunader A, Rouillier S, Lopez de Degani G, Seidenstein E, Prentl E, Anton J, Krahenmann F, Nowacki D, Poncelas M, Nassif JC, Papera R, Tuma C, Espoile R, Tiberio O, Breccia G, Messina A, Peker B, Schinner E, Mol BW, Kanterewicz L, Wainer V, Boulvain M, Othenin-Girard V, Bertolino MV, Irion O; 4P trial group. Prevention of preterm delivery with vaginal progesterone in women with preterm labour (4P): randomised double-blind placebo-controlled trial. BJOG. 2015 Jan;122(1):80-91. doi: 10.1111/1471-0528.13061. Epub 2014 Sep 11.

    PubMed 25209926

  • Borna S, Sahabi N. Progesterone for maintenance tocolytic therapy after threatened preterm labour: a randomised controlled trial. Aust N Z J Obstet Gynaecol. 2008 Feb;48(1):58-63. doi: 10.1111/j.1479-828X.2007.00803.x.

    PubMed 18275573

  • Arikan I, Barut A, Harma M, Harma IM. Effect of progesterone as a tocolytic and in maintenance therapy during preterm labor. Gynecol Obstet Invest. 2011;72(4):269-73. doi: 10.1159/000328719. Epub 2011 Nov 12.

    PubMed 22086108

Questions about this trial

What is this clinical trial studying?

A study testing progesterone, Tocolytics and Steroids in people with Preterm Labor, run by Chulalongkorn University at 1 site in Thailand.

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 1 inclusion and 6 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: finished, as of the sponsor's last update on 31 Jan 2019. 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 Thailand. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time from preterm labor pain to delivery (time frame: 9 weeks). 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 NCT03202836, which also lists 11 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 31 Jan 2019.

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