Threatened AbortionPhase 4NCT04788108
Oral Progesterone for Prevention of Miscarriage in Threatened Abortion
A Phase 4 study testing Dydrogesterone in people with Threatened Abortion, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study evaluates the effectiveness of oral dydrogesterone in preventing miscarriage in threatened abortion. Half of participants will receive oral dydrogesterone, while the other half will receive oral placebo. 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
- Threatened Abortion
- 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
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2021to 31 Aug 2022
- 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 6 - 20 weeks
- threatened abortion
- confirmed intrauterine pregnancy with a viable fetus by ultrasound
Who cannot join
- history of recurrent miscarriage
- having endocervical polyp
- having infection such as pneumonia, pyelonephritis, septicemia
- having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis
- having cancer
- having coagulation defect
- allergy to dydrogesterone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Progesterone for Prevention of Miscarriage in Threatened Abortion: a Randomized, Double-blinded, Placebo-controlled Trial
This study evaluates the effectiveness of oral dydrogesterone in preventing miscarriage in threatened abortion. Half of participants will receive oral dydrogesterone, while the other half will receive oral placebo.
- Conditions
- Threatened Abortion
- Being tested
- Dydrogesterone, Placebo
- Keywords
- threatened abortion
- Medical subject headings
- Abortion, Threatened
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DydrogesteroneDrug
Dydrogesterone tablet
PlaceboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Dydrogesterone | Active comparator | dydrogesterone 10 mg by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks. Receives: Drug: Dydrogesterone |
| Placebo | Placebo comparator | placebo by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
continue pregnancy more than 20 weeks gestation
percentage of cases with continue pregnancy more than 20 weeks gestation
Measured: at 20 weeks gestation
Secondary outcomes (10)
preterm delivery less than 34 weeks
percentage of delivery less than 34 weeks
Measured: at 34 weeks gestation
preterm delivery less than 37 weeks
percentage of delivery less than 37 weeks
Measured: at 37 weeks gestation
placenta previa
percentage of placenta previa
Measured: 31 weeks
abruptio placenta
percentage of abruptio placenta
Measured: 31 weeks
Intrauterine growth restriction
percentage of intrauterine growth restriction
Measured: 31 weeks
neonatal complications
percentage of newborn with respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, death
Measured: 31 weeks
side effects
percentage of side effects such as headache, nausea/vomiting
Measured: 6 weeks
compliance
percentage of complete drug use
Measured: 6 weeks
maternal satisfaction
percentage of good satisfaction
Measured: 6 weeks
time until bleeding stops
time from first bleeding until bleeding stops
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Aug 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Threatened AbortionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 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
- NCT04788108
- Sponsor's protocol ID
- 177/2021
- Status last verified
- Aug 2023
- First submitted
- 2 Mar 2021
- Last updated
- 30 Aug 2023
- 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-Gynecology. ACOG Practice Bulletin No. 200: Early Pregnancy Loss. Obstet Gynecol. 2018 Nov;132(5):e197-e207. doi: 10.1097/AOG.0000000000002899.
PubMed 30157093Mirza FG, Patki A, Pexman-Fieth C. Dydrogesterone use in early pregnancy. Gynecol Endocrinol. 2016;32(2):97-106. doi: 10.3109/09513590.2015.1121982. Epub 2016 Jan 22.
PubMed 26800266Schindler AE, Campagnoli C, Druckmann R, Huber J, Pasqualini JR, Schweppe KW, Thijssen JH. Classification and pharmacology of progestins. Maturitas. 2003 Dec 10;46 Suppl 1:S7-S16. doi: 10.1016/j.maturitas.2003.09.014.
PubMed 14670641Omar MH, Mashita MK, Lim PS, Jamil MA. Dydrogesterone in threatened abortion: pregnancy outcome. J Steroid Biochem Mol Biol. 2005 Dec;97(5):421-5. doi: 10.1016/j.jsbmb.2005.08.013. Epub 2005 Nov 15.
PubMed 16293412Pandian RU. Dydrogesterone in threatened miscarriage: a Malaysian experience. Maturitas. 2009 Dec;65 Suppl 1:S47-50. doi: 10.1016/j.maturitas.2009.11.016. Epub 2009 Dec 14.
PubMed 20005647El-Zibdeh MY, Yousef LT. Dydrogesterone support in threatened miscarriage. Maturitas. 2009 Dec;65 Suppl 1:S43-6. doi: 10.1016/j.maturitas.2009.11.013. Epub 2009 Dec 14.
PubMed 20007011
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Progesterone for Prevention of Miscarriage in Threatened Abortion: a Randomized, Double-blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04788108
- Acronym / sponsor ID
- 177/2021
- Conditions
- Threatened Abortion
- Keywords
- threatened abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 9 Mar 2021 (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 effectiveness of oral dydrogesterone in preventing miscarriage in threatened abortion. Half of participants will receive oral dydrogesterone, while the other half will receive oral placebo.
Study design
- Primary purpose
- Prevention
- 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 12 hours until 1 week after bleeding stops or until 6 weeks. |
| Placebo | Placebo comparator | Drug: Placeboplacebo by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks. |
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 6 - 20 weeks
- threatened abortion
- confirmed intrauterine pregnancy with a viable fetus by ultrasound
Key exclusion criteria (7 listed)
- history of recurrent miscarriage
- having endocervical polyp
- having infection such as pneumonia, pyelonephritis, septicemia
- having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis
- having cancer
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 tablet | Drug | Dydrogesterone |
| PlaceboPlacebo tablet | Drug | Placebo |
Primary outcome
continue pregnancy more than 20 weeks gestation
Time frame: at 20 weeks gestation
percentage of cases with continue pregnancy more than 20 weeks gestation
10 secondary outcomes
preterm delivery less than 34 weeks
Time frame: at 34 weeks gestation
preterm delivery less than 37 weeks
Time frame: at 37 weeks gestation
placenta previa
Time frame: 31 weeks
abruptio placenta
Time frame: 31 weeks
Intrauterine growth restriction
Time frame: 31 weeks
neonatal complications
Time frame: 31 weeks
side effects
Time frame: 6 weeks
compliance
Time frame: 6 weeks
maternal satisfaction
Time frame: 6 weeks
time until bleeding stops
Time frame: 6 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 30 Aug 2023.
- Background: PubMed 30157093American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin No. 200: Early Pregnancy Loss. Obstet Gynecol. 2018 Nov;132(5):e197-e207. doi: 10.1097/AOG.0000000000002899.
- Background: PubMed 26800266Mirza FG, Patki A, Pexman-Fieth C. Dydrogesterone use in early pregnancy. Gynecol Endocrinol. 2016;32(2):97-106. doi: 10.3109/09513590.2015.1121982. Epub 2016 Jan 22.
- Background: PubMed 14670641Schindler AE, Campagnoli C, Druckmann R, Huber J, Pasqualini JR, Schweppe KW, Thijssen JH. Classification and pharmacology of progestins. Maturitas. 2003 Dec 10;46 Suppl 1:S7-S16. doi: 10.1016/j.maturitas.2003.09.014.
- Results publication: PubMed 16293412Omar MH, Mashita MK, Lim PS, Jamil MA. Dydrogesterone in threatened abortion: pregnancy outcome. J Steroid Biochem Mol Biol. 2005 Dec;97(5):421-5. doi: 10.1016/j.jsbmb.2005.08.013. Epub 2005 Nov 15.
- Results publication: PubMed 20005647Pandian RU. Dydrogesterone in threatened miscarriage: a Malaysian experience. Maturitas. 2009 Dec;65 Suppl 1:S47-50. doi: 10.1016/j.maturitas.2009.11.016. Epub 2009 Dec 14.
- Results publication: PubMed 20007011El-Zibdeh MY, Yousef LT. Dydrogesterone support in threatened miscarriage. Maturitas. 2009 Dec;65 Suppl 1:S43-6. doi: 10.1016/j.maturitas.2009.11.013. Epub 2009 Dec 14.
- Individual participant dataSharing planned: Undecided
Related trials for Threatened Abortion
Not yet recruitingObservational study
Serum Progesterone and Threatened Abortion During Lactation
Threatened Abortion
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 Threatened Abortion, 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 7 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 30 Aug 2023. 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?
continue pregnancy more than 20 weeks gestation (time frame: at 20 weeks gestation). 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 NCT04788108, which also lists 6 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 30 Aug 2023.