Preterm BirthPhase 4prematurityNCT05319834
Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth
A Phase 4 study testing Aspirin tablet in people with Preterm Birth, run by Menoufia University at 1 site in Egypt.
Trial summary
This is a double blinded randomized placebo controlled clinical trial to detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Aspirin tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 31 Dec 2023
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women of any age
- Any parity
- Healthy singleton pregnancy
- History suggestive of one or more previous PTB
- Current pregnancy (16-20) weeks gestation.
Who cannot join
- Multifetal pregnancy.
- History of ante partum PROM.
- Cervical Incompetence or current cervical cerclage.
- Known fetal anomaly.
- Hypertension requiring medications.
- History of Thrombo-embolic disorders.
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- Known allergy to progesterone or asprin.
- Known liver disease.
- Established preterm labor
- Short cervix
Trial locations and contacts
1 site in 1 country.
About this study
This is a double blinded randomized placebo controlled clinical trial to detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.
Read the detailed description
The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1), or vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).
- Conditions
- Preterm Birth
- Being tested
- Aspirin tablet, Placebo
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin tabletDrug
Also called group 1 intervention
group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone
PlaceboDrug
Also called group 2 intervention
group 2: oral placebo once daily at the same time with progesterone
| Study group | Role | What they receive |
|---|---|---|
| Progesterone with asprin | Active comparator | The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1), Receives: Drug: Aspirin tablet |
| Progesterone and placebo | Placebo comparator | vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who will deliver before 34 weeks gestation.
Number of participants who have preterm delivery before 34 weeks gestation
Measured: 18 month
Secondary outcomes (2)
The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation
Number of participants who will deliver after 34w gestation and neonatal outcomes
Measured: 18 months
Neonatal outcomes
Neonatal birth weight Admission to NICU Neonatal complications
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Maher, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319834
- Sponsor's protocol ID
- 3/2020/OBG
- Acronym
- prematurity
- Status last verified
- Jan 2024
- First submitted
- 22 Mar 2022
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth
- ClinicalTrials.gov ID
- NCT05319834
- Acronym / sponsor ID
- prematurity / 3/2020/OBG
- Conditions
- Preterm Birth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Apr 2022 (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 is a double blinded randomized placebo controlled clinical trial to detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.
Detailed description
The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1), or vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- To detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.
| Arm | Type | Receives |
|---|---|---|
| Progesterone with asprin | Active comparator | Drug: Aspirin tabletThe included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1), |
| Progesterone and placebo | Placebo comparator | Drug: Placebovaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Women of any age
- Any parity
- Healthy singleton pregnancy
- History suggestive of one or more previous PTB
- Current pregnancy (16-20) weeks gestation.
Key exclusion criteria (10 listed)
- Multifetal pregnancy.
- History of ante partum PROM.
- Cervical Incompetence or current cervical cerclage.
- Known fetal anomaly.
- Hypertension requiring medications.
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 |
|---|---|---|
| Aspirin tabletAlso: group 1 interventiongroup1: oral aspirin at a dose of 100mg once daily at the same time with progesterone | Drug | Progesterone with asprin |
| PlaceboAlso: group 2 interventiongroup 2: oral placebo once daily at the same time with progesterone | Drug | Progesterone and placebo |
Primary outcome
Number of participants who will deliver before 34 weeks gestation.
Time frame: 18 month
Number of participants who have preterm delivery before 34 weeks gestation
2 secondary outcomes
The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation
Time frame: 18 months
Neonatal outcomes
Time frame: 18 months
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 16 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aspirin tablet in people with Preterm Birth, run by Menoufia University at 1 site in Egypt.
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 5 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 16 Jan 2024. 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 Egypt. 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?
Number of participants who will deliver before 34 weeks gestation. (time frame: 18 month). 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 16 Jan 2024.