Preterm LaborPhase 4NCT03935152
Oral Dydrogesterone in the Management of Preterm Labor
A Phase 4 study testing Dydrogesterone in people with Preterm Labor, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study evaluates the addition of oral dydrogesterone to standard treatment in the treatment of preterm labor. Half of participants will receive oral dydrogesterone and standard treatment, while the other half will receive oral placebo and standard treatment. 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?
- Dydrogesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteThailand
- Study dates
- 11 May 2019to 31 May 2020
- Phase
- Phase 4
- 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 pregnancy with gestational age 24-33 weeks 6 days
- preterm labor
- received treatment with tocolysis and corticosteroids
Who cannot join
- conditions that need immediate delivery such as fetal distress, chorioamnionitis
- have medical complications such as heart disease, seizure
- fetal anomalies
- cervical dilatation more than 5 cm
- allergy to dydrogesterone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Dydrogesterone as Adjunctive Therapy in the Management of Preterm Labor: A Randomized, Double Blinded, Placebo-controlled Trial
This study evaluates the addition of oral dydrogesterone to standard treatment in the treatment of preterm labor. Half of participants will receive oral dydrogesterone and standard treatment, while the other half will receive oral placebo and standard treatment.
- Conditions
- Preterm Labor
- Being tested
- Dydrogesterone, placebo
- 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.
DydrogesteroneDrug
dydrogesterone capsule
placeboDrug
placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Dydrogesterone | Active comparator | dydrogesterone 10 mg by mouth every 8 hours until delivery Receives: Drug: Dydrogesterone |
| Placebo | Placebo comparator | placebo by mouth every 8 hours until delivery Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
latency period
time from preterm labor to delivery
Measured: 13 weeks
Secondary outcomes (7)
preterm delivery less than 34 weeks
percentage of delivery less than 34 weeks
Measured: 10 weeks
preterm delivery less than 37 weeks
percentage of delivery less than 37 weeks
Measured: 13 weeks
neonatal complications
percentage of newborn with RDS, IVH, NEC, death
Measured: 13 weeks
side effects
percentage of side effects such as headache, nausea/vomiting
Measured: 13 weeks
compliance
percentage of complete drug use
Measured: 13 weeks
satisfaction
percentage of good satisfaction
Measured: 13 weeks
Time to the recurrence of uterine contractions
Time to the recurrence of uterine contractions
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start11 May 2019
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vorapong Phupong, Chulalongkorn University
- Investigators
- Vorapong Phupong, M.D., Study director, Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935152
- Sponsor's protocol ID
- 286/2019
- Status last verified
- Jan 2021
- First submitted
- 30 Apr 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 171: Management of Preterm Labor. Obstet Gynecol. 2016 Oct;128(4):e155-64. doi: 10.1097/AOG.0000000000001711.
PubMed 27661654Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB, Kinney M, Lawn J; Born Too Soon Preterm Birth Action Group. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;10 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15.
PubMed 24625129Norwitz ER, Caughey AB. Progesterone supplementation and the prevention of preterm birth. Rev Obstet Gynecol. 2011 Summer;4(2):60-72.
PubMed 22102929Yasuda K, Sumi GI, Murata H, Kida N, Kido T, Okada H. The steroid hormone dydrogesterone inhibits myometrial contraction independently of the progesterone/progesterone receptor pathway. Life Sci. 2018 Aug 15;207:508-515. doi: 10.1016/j.lfs.2018.07.004. Epub 2018 Jul 4.
PubMed 29981319Schindler AE, Campagnoli C, Druckmann R, Huber J, Pasqualini JR, Schweppe KW, Thijssen JH. Classification and pharmacology of progestins. Maturitas. 2008 Sep-Oct;61(1-2):171-80. doi: 10.1016/j.maturitas.2008.11.013.
PubMed 19434889Borna 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 18275573Arikan 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 22086108Choudhary M, Suneja A, Vaid NB, Guleria K, Faridi MM. Maintenance tocolysis with oral micronized progesterone for prevention of preterm birth after arrested preterm labor. Int J Gynaecol Obstet. 2014 Jul;126(1):60-3. doi: 10.1016/j.ijgo.2014.01.019. Epub 2014 Apr 3.
PubMed 24807871Areeruk W, Phupong V. A randomized, double blinded, placebo controlled trial of oral dydrogesterone supplementation in the management of preterm labor. Sci Rep. 2016 Feb 9;6:20638. doi: 10.1038/srep20638.
PubMed 26856618Thongchan S, Phupong V. Oral dydrogesterone as an adjunctive therapy in the management of preterm labor: a randomized, double blinded, placebo-controlled trial. BMC Pregnancy Childbirth. 2021 Jan 28;21(1):90. doi: 10.1186/s12884-021-03562-6.
PubMed 33509129
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Dydrogesterone as Adjunctive Therapy in the Management of Preterm Labor: A Randomized, Double Blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03935152
- Acronym / sponsor ID
- 286/2019
- Conditions
- Preterm Labor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 11 May 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the addition of oral dydrogesterone to standard treatment in the treatment of preterm labor. Half of participants will receive oral dydrogesterone and standard treatment, while the other half will receive oral placebo and standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dydrogesterone | Active comparator | Drug: Dydrogesteronedydrogesterone 10 mg by mouth every 8 hours until delivery |
| Placebo | Placebo comparator | Drug: placeboplacebo by mouth every 8 hours until delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- singleton pregnancy with gestational age 24-33 weeks 6 days
- preterm labor
- received treatment with tocolysis and corticosteroids
Key exclusion criteria (5 listed)
- conditions that need immediate delivery such as fetal distress, chorioamnionitis
- have medical complications such as heart disease, seizure
- fetal anomalies
- cervical dilatation more than 5 cm
- allergy to dydrogesterone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dydrogesteronedydrogesterone capsule | Drug | Dydrogesterone |
| placeboplacebo capsule | Drug | Placebo |
Primary outcome
latency period
Time frame: 13 weeks
time from preterm labor to delivery
7 secondary outcomes
preterm delivery less than 34 weeks
Time frame: 10 weeks
preterm delivery less than 37 weeks
Time frame: 13 weeks
neonatal complications
Time frame: 13 weeks
side effects
Time frame: 13 weeks
compliance
Time frame: 13 weeks
satisfaction
Time frame: 13 weeks
Time to the recurrence of uterine contractions
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Background: PubMed 27661654American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 171: Management of Preterm Labor. Obstet Gynecol. 2016 Oct;128(4):e155-64. doi: 10.1097/AOG.0000000000001711.
- Background: PubMed 24625129Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB, Kinney M, Lawn J; Born Too Soon Preterm Birth Action Group. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;10 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15.
- Background: PubMed 22102929Norwitz ER, Caughey AB. Progesterone supplementation and the prevention of preterm birth. Rev Obstet Gynecol. 2011 Summer;4(2):60-72.
- Background: PubMed 29981319Yasuda K, Sumi GI, Murata H, Kida N, Kido T, Okada H. The steroid hormone dydrogesterone inhibits myometrial contraction independently of the progesterone/progesterone receptor pathway. Life Sci. 2018 Aug 15;207:508-515. doi: 10.1016/j.lfs.2018.07.004. Epub 2018 Jul 4.
- Background: PubMed 19434889Schindler AE, Campagnoli C, Druckmann R, Huber J, Pasqualini JR, Schweppe KW, Thijssen JH. Classification and pharmacology of progestins. Maturitas. 2008 Sep-Oct;61(1-2):171-80. doi: 10.1016/j.maturitas.2008.11.013.
- Results publication: PubMed 18275573Borna 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.
- Results publication: PubMed 22086108Arikan 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.
- Results publication: PubMed 24807871Choudhary M, Suneja A, Vaid NB, Guleria K, Faridi MM. Maintenance tocolysis with oral micronized progesterone for prevention of preterm birth after arrested preterm labor. Int J Gynaecol Obstet. 2014 Jul;126(1):60-3. doi: 10.1016/j.ijgo.2014.01.019. Epub 2014 Apr 3.
- Results publication: PubMed 26856618Areeruk W, Phupong V. A randomized, double blinded, placebo controlled trial of oral dydrogesterone supplementation in the management of preterm labor. Sci Rep. 2016 Feb 9;6:20638. doi: 10.1038/srep20638.
- Derived from this study: PubMed 33509129Thongchan S, Phupong V. Oral dydrogesterone as an adjunctive therapy in the management of preterm labor: a randomized, double blinded, placebo-controlled trial. BMC Pregnancy Childbirth. 2021 Jan 28;21(1):90. doi: 10.1186/s12884-021-03562-6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vorapong Phupong, M.D. study director
Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dydrogesterone 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 3 inclusion and 5 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 22 Jan 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 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. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
latency period (time frame: 13 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 NCT03935152, which also lists 10 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 22 Jan 2021.