Pregnant WomenNCT06975943
Comparison in Cervical Length and Prolongation of Gestation Age on Vaginal Progesterone Administration to Pregnant Women After the Acute Phase of Threatened Preterm Birth
A study testing Progesterone 200 mg vaginal capsules in people with Pregnant Women and Pregnancies at Increased Risk of Preterm Birth, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
Trial summary
This randomised clinical trial aims to investigate the effect of daily vaginal progesterone supplementation on pregnancy prolongation and cervical length changes following arrested preterm labor in singleton pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnant Women, Pregnancies at Increased Risk of Preterm Birth
- What is being tested?
- Progesterone 200 mg vaginal capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2025to 28 Feb 2026
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnant women who have passed the acute phase of Threatened Preterm Labor that meets the following criteria:
- Persistent contractions (2-3 contractions in 10 minutes) accompanied by cervical dilation assessed based on pelvic examination (Vaginal Touche)
- Intact amniotic membrane
- Cervical dilation ≤ 2 cm
- No birth occurs within 2x24 hours since persistent contractions appear.
- Age 18-40 years
- The gestational age must be between 28 weeks and 33 weeks plus 6 days.
- Able to participate, communicate well with researchers, and willing to provide written consent to participate in the study.
Who cannot join
- Patients with cervical cerclage in this pregnancy
- Cervical length is less than 10 mm
- Congenital abnormalities in the fetus
- Anatomical abnormalities in the uterus
- History of antepartum hemorrhage in this pregnancy
- Known hypersensitivity to progesterone or contraindications to its use.
Show all 10Show fewer
- Suspected or proven premature rupture of membranes at enrollment
- Subjects on drug therapy known to interact with progesterone (eg Bromocriptine, Rifampin, Ketoconazole, and Cyclosporine)
- Subjects with comorbidities: cardiovascular disease, renal function, liver function, hematological disorders, and other uncontrolled comorbidities.
- Subjects with stress conditions based on the DASS-42 questionnaire.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Soetomo General Hospital Surabaya
Surabaya, East Java, 60286
About this study
Official title: Comparison in Cervical Length and Prolongation of Gestation Age on Vaginal Progesterone Administration to Pregnant Women After the Acute Phase of Threatened Preterm Birth : A Randomised Clinical Trial
This randomised clinical trial aims to investigate the effect of daily vaginal progesterone supplementation on pregnancy prolongation and cervical length changes following arrested preterm labor in singleton pregnancies. The study will recruit pregnant women between 28 and 33 weeks of gestational age who had experienced threatened preterm labor at Dr. Soetomo Hospital in Indonesia. Participants will be randomly divided into two groups: a Treatment Group receiving vaginal progesterone therapy and a Control Group receiving standard care without progesterone intervention. The primary outcomes are the prolongation of gestational age until delivery and the changes in cervical length over time. The secondary outcomes are recurrence of threatened preterm labor, mode of delivery, neonatal outcomes, and survival analysis. This study will provide valuable evidence supporting the use of vaginal progesterone as an effective intervention for women at risk of preterm labor and potentially improving maternal and neonatal outcomes in Indonesia and globally. All participants will be provided with detailed information about the study, and their participation will be voluntary. Ethical considerations, including informed consent and data confidentiality, will be strictly adhered to throughout the study.
Read the detailed description
This prospective, open-label, randomised clinical trial aims to investigate the effect of daily vaginal progesterone supplementation on pregnancy prolongation and cervical length changes following arrested preterm labor in singleton pregnancies. Threatened preterm labor is characterised by rhythmic uterine contractions occurring without substantial cervical changes, as assessed through digital pelvic examination. The gestational age will be verified via ultrasound metrics and review of antenatal care documentation. All subjects will receive standard tocolytic treatment, oral nifedipine for 48 hours in conjunction with dexamethasone injections to promote fetal lung development. The arrest of preterm labor is characterised by a stable condition that does not advance to active labor, specifically defined as two or fewer contractions per ten minutes, intact membranes, and cervical dilatation of three centimetres or less, following a minimum of 48 hours after the first dose of tocolytics. Women will be enrolled 48 hours after tocolytic initiation. Upon obtaining written informed consent from the participants, baseline data will be collected for each individual. The baseline data comprise demographic and clinical information, including risk factors, digital pelvic examinations, and ultrasound findings. All participants will receive a digital pelvic examination to assess cervical dilation and effacement, as well as a transvaginal ultrasound to measure cervical length. Cervical length will be assessed by Ernawati at Dr. Soetomo Hospital utilising a standard procedure with a probe encased in a disposable cover, which is then inserted vaginally with an empty bladder. The cervical length will be reassessed at outpatient clinic visits at 7 days and 14 days post-enrollment. Subsequent to the acquisition of baseline data, all participants will be randomly allocated into two groups: the Control Group, which does not receive therapy, and the Therapy Group, which will receive vaginal progesterone. Ethical considerations are of utmost importance in this study. The study protocol will undergo evaluation and approval by an Institutional Review Board (IRB) or equivalent ethical committee. Confidentiality of participants will be preserved during the study, and data will be anonymised throughout analysis and reporting. All potential hazards related to the examination or drug administration will be comprehensively communicated to participants, and suitable safety protocols will be established. Participants will be notified of their right to withdraw from the study at any period without penalty.
- Being tested
- Progesterone 200 mg vaginal capsules
- Keywords
- Interventional, Pregnant Women, Preterm Birth, Vaginal Progesterone, Indonesia
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone 200 mg vaginal capsulesDrug
Also called Microgest
Participants in this group will receive daily vaginal micronized progesterone (Microgest®) of dose 200 mg for a duration of two weeks following arrested preterm labor. This micronized progesterone will be administered to assess its impact on pregnancy prolongation and changes of cervical length following arrested preterm labor.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group will receive standard tocolytic treatment, receiving oral nifedipine for 48 hours in conjunction with dexamethasone injections to promote fetal lung development. Participants will have no progesterone treatment following arrested preterm labor. Monitoring for compliance will be conducted throughout the study period. |
| Vaginal Progesterone | Active comparator | This group will receive standard tocolytic treatment, receiving oral nifedipine for 48 hours in conjunction with dexamethasone injections to promote fetal lung development. Participants will receive daily vaginal micronized progesterone (Microgest®) of dose 200 mg for a duration of two weeks following arrested preterm labor. Monitoring for compliance and potential side effects will be conducted throughout the study period. Receives: Drug: Progesterone 200 mg vaginal capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolongation of Gestation Age
This measurement will be confirmed through ultrasound parameters and review of antenatal care records for gestation age at enrollment. Then the next measurement will be at delivery. Prolongation of gestation age will be measured in days.
Measured: Enrollment and Delivery
Changes of Cervical Length
This measurement will be confirmed through transvaginal ultrasound parameters at enrollment. The next measurement will be at subsequent obstetric clinic visits. Changes in cervical length will be measured in millimeters.
Measured: Enrollment, 7th and 14th day after enrollment
Secondary outcomes (6)
Recurrence of Threatening Preterm Labor
This measures the incidence of threatening preterm labor recurrence throughout the study.
Measured: 7th, 14th day after enrollment, and Delivery
Delivery Method
Delivery method will be categorized as spontaneous vaginal delivery, operative vaginal delivery, and cesarean section.
Measured: Delivery
APGAR Score
This measure is a newborn health assessment system that is carried out by checking five vital criteria at the 1st and 5th minute. There are 5 parts to an Apgar score. Each category is weighted evenly and assigned a 0, 1, or 2 value. The components are then added to give a score recorded 1 and 5 minutes after birth. A score of 7 to 10 is considered reassuring, a score of 4 to 6 is moderately abnormal, and a score of 0 to 3 is deemed low in full-term and late preterm infants.
Measured: Delivery
Baby Birth Weight
This measures the weight of the baby birth. The weight will be measured in grams.
Measured: Delivery
NICU Admission
This measures how many newborns that was given intensive care.
Measured: Delivery
Neonatal Mortality
This measures the number of fetal and newborn deaths under 28 days of age.
Measured: Delivery and 28 days post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Jan 2025
- Primary completion5 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ernawati Ernawati, Dr., Principal investigator, Dr. Soetomo General Hospital Surabaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975943
- Sponsor's protocol ID
- 0976/KEPK/V/2024
- Status last verified
- Jul 2026
- First submitted
- 9 May 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this point, we remain undecided about disseminating Individual Participant Data (IPD) from this study to other researchers. Multiple elements are now being evaluated, encompassing the prospective advantages of data sharing for the enhancement of scientific knowledge, alongside the ethical and logistical problems related to safeguarding participant privacy and data security. We are assessing the criteria and regulations of prospective data repositories and funding organizations. A conclusive decision will be reached following thorough consideration and consultation with pertinent parties, including the Institutional Review Board (IRB) or ethical committee, and will be properly documented.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison in Cervical Length and Prolongation of Gestation Age on Vaginal Progesterone Administration to Pregnant Women After the Acute Phase of Threatened Preterm Birth : A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06975943
- Acronym / sponsor ID
- 0976/KEPK/V/2024
- Keywords
- Interventional, Pregnant Women, Preterm Birth, Vaginal Progesterone, Indonesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 16 May 2025 (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 randomised clinical trial aims to investigate the effect of daily vaginal progesterone supplementation on pregnancy prolongation and cervical length changes following arrested preterm labor in singleton pregnancies. The study will recruit pregnant women between 28 and 33 weeks of gestational age who had experienced threatened preterm labor at Dr. Soetomo Hospital in Indonesia. Participants will be randomly divided into two groups: a Treatment Group receiving vaginal progesterone therapy and a Control Group receiving standard care without progesterone intervention. The primary outcomes are the prolongation of gestational age until delivery and the changes in cervical length over time. The secondary outcomes are recurrence of threatened preterm labor, mode of delivery, neonatal outcomes, and survival analysis. This study will provide valuable evidence supporting the use of vaginal progesterone as an effective intervention for women at risk of preterm labor and potentially improving maternal and neonatal outcomes in Indonesia and globally. All participants will be provided with detailed information about the study, and their participation will be voluntary. Ethical considerations, including informed consent and data confidentiality, will be strictly adhered to throughout the study.
Detailed description
This prospective, open-label, randomised clinical trial aims to investigate the effect of daily vaginal progesterone supplementation on pregnancy prolongation and cervical length changes following arrested preterm labor in singleton pregnancies. Threatened preterm labor is characterised by rhythmic uterine contractions occurring without substantial cervical changes, as assessed through digital pelvic examination. The gestational age will be verified via ultrasound metrics and review of antenatal care documentation. All subjects will receive standard tocolytic treatment, oral nifedipine for 48 hours in conjunction with dexamethasone injections to promote fetal lung development. The arrest of preterm labor is characterised by a stable condition that does not advance to active labor, specifically defined as two or fewer contractions per ten minutes, intact membranes, and cervical dilatation of three centimetres or less, following a minimum of 48 hours after the first dose of tocolytics. Women will be enrolled 48 hours after tocolytic initiation. Upon obtaining written informed consent from the participants, baseline data will be collected for each individual. The baseline data comprise demographic and clinical information, including risk factors, digital pelvic examinations, and ultrasound findings. All participants will receive a digital pelvic examination to assess cervical dilation and effacement, as well as a transvaginal ultrasound to measure cervical length. Cervical length will be assessed by Ernawati at Dr. Soetomo Hospital utilising a standard procedure with a probe encased in a disposable cover, which is then inserted vaginally with an empty bladder. The cervical length will be reassessed at outpatient clinic visits at 7 days and 14 days post-enrollment. Subsequent to the acquisition of baseline data, all participants will be randomly allocated into two groups: the Control Group, which does not receive therapy, and the Therapy Group, which will receive vaginal progesterone. Ethical considerations are of utmost importance in this study. The study protocol will undergo evaluation and approval by an Institutional Review Board (IRB) or equivalent ethical committee. Confidentiality of participants will be preserved during the study, and data will be anonymised throughout analysis and reporting. All potential hazards related to the examination or drug administration will be comprehensively communicated to participants, and suitable safety protocols will be established. Participants will be notified of their right to withdraw from the study at any period without penalty.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group will receive standard tocolytic treatment, receiving oral nifedipine for 48 hours in conjunction with dexamethasone injections to promote fetal lung development. Participants will have no progesterone treatment following arrested preterm labor. Monitoring for compliance will be conducted throughout the study period. |
| Vaginal Progesterone | Active comparator | Drug: Progesterone 200 mg vaginal capsulesThis group will receive standard tocolytic treatment, receiving oral nifedipine for 48 hours in conjunction with dexamethasone injections to promote fetal lung development. Participants will receive daily vaginal micronized progesterone (Microgest®) of dose 200 mg for a duration of two weeks following arrested preterm labor. Monitoring for compliance and potential side effects will be conducted throughout the study period. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Singleton pregnant women who have passed the acute phase of Threatened Preterm Labor that meets the following criteria:
- Age 18-40 years
- The gestational age must be between 28 weeks and 33 weeks plus 6 days.
- Able to participate, communicate well with researchers, and willing to provide written consent to participate in the study.
Key exclusion criteria (10 listed)
- Patients with cervical cerclage in this pregnancy
- Cervical length is less than 10 mm
- Congenital abnormalities in the fetus
- Anatomical abnormalities in the uterus
- History of antepartum hemorrhage in this pregnancy
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 |
|---|---|---|
| Progesterone 200 mg vaginal capsulesAlso: MicrogestParticipants in this group will receive daily vaginal micronized progesterone (Microgest®) of dose 200 mg for a duration of two weeks following arrested preterm labor. This micronized progesterone will be administered to assess its impact on pregnancy prolongation and changes of cervical length following arrested preterm labor. | Drug | Vaginal Progesterone |
Primary outcome
Prolongation of Gestation Age
Time frame: Enrollment and Delivery
This measurement will be confirmed through ultrasound parameters and review of antenatal care records for gestation age at enrollment. Then the next measurement will be at delivery. Prolongation of gestation age will be measured in days.
Changes of Cervical Length
Time frame: Enrollment, 7th and 14th day after enrollment
This measurement will be confirmed through transvaginal ultrasound parameters at enrollment. The next measurement will be at subsequent obstetric clinic visits. Changes in cervical length will be measured in millimeters.
6 secondary outcomes
Recurrence of Threatening Preterm Labor
Time frame: 7th, 14th day after enrollment, and Delivery
Delivery Method
Time frame: Delivery
APGAR Score
Time frame: Delivery
Baby Birth Weight
Time frame: Delivery
NICU Admission
Time frame: Delivery
Neonatal Mortality
Time frame: Delivery and 28 days post partum
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 28 Aug 2026.
- Individual participant dataSharing planned: Undecided. At this point, we remain undecided about disseminating Individual Participant Data (IPD) from this study to other researchers. Multiple elements are now being evaluated, encompassing the prospective advantages of data sharing for the enhancement of scientific knowledge, alongside the ethical and logistical problems related to safeguarding participant privacy and data security. We are assessing the criteria and regulations of prospective data repositories and funding organizations. A conclusive decision will be reached following thorough consideration and consultation with pertinent parties, including the Institutional Review Board (IRB) or ethical committee, and will be properly documented.
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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.
Ernawati Ernawati, Dr. principal investigator
Dr. Soetomo General Hospital Surabaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progesterone 200 mg vaginal capsules in people with Pregnant Women and Pregnancies at Increased Risk of Preterm Birth, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
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 8 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: finished, as of the sponsor's last update on 28 Aug 2026. 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 Indonesia. 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?
Prolongation of Gestation Age (time frame: Enrollment and Delivery). 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?
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 28 Aug 2026.