Preterm BirthPhase 2/3PPPTPNCT02350231
Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth
A Phase 2/3 study testing The progesterone vaginal pessary and Tonics group in people with Preterm Birth, run by Assiut University.
Trial summary
Multiple pregnancies accounted for 1 - 6 % of all births in UK during 2007. More than 98% of these multiple births being twin births . Preterm birth defined as birth occurring prior to 37 weeks of gestation and it was about 15 % of pregnancies in developed world and 12.7 % in the United States. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- The progesterone vaginal pessary and Tonics group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2014to 15 Jan 2017
- Phase
- Phase 2/3
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diamniotic twin pregnancy
- Gestational age ± 28 weeks.
Who cannot join
- Higher multiple pregnancy
- IUFD of one or both fetuses
- Any congenital anomalies
- IUGR or discordant twins
- PROM
- If there is any contraindication to progesterone treatment
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- Women who did performed cervical cerclage in the current pregnancy
- Difficult in follow up for the pregnant women as (living faraway area, or difficult transportion, etc).
- Threatened preterm labor.
- Polyhydromnis.
- Other medical disorder with pregnancy
About this study
Multiple pregnancies accounted for 1 - 6 % of all births in UK during 2007. More than 98% of these multiple births being twin births . Preterm birth defined as birth occurring prior to 37 weeks of gestation and it was about 15 % of pregnancies in developed world and 12.7 % in the United States.
Preterm birth is the leading cause of infant and neonatal mortality. Premature neonates are at increased risk of developing respiratory distress syndrome, sepsis, intraventricular hemorrhage, and necrotizing enterocolitis.
Read more
Twin pregnancy is considered one of the important risk factors of preterm birth. Over distension of uterus may be one of the etiological factors for preterm birth. However, no definite effective interventions have been shown to prevent preterm delivery in twin pregnancy.
Three large randomized trials suggested that progesterone might prevent preterm delivery in high-risk singleton pregnancy especially those with previous preterm delivery or short cervix might be reduced by antenatal progesterone.
Fonseca et al (2007) concluded that women with short cervix are less likely to deliver preterm ≤34 weeks if they are treated with vaginal progesterone.
- Conditions
- Preterm Birth
- Being tested
- The progesterone vaginal pessary, Tonics group
- Keywords
- preterm birth, Twin pregnancy, progesterone
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The progesterone vaginal pessaryDrug
Also called Active drug treatment
Those patients will receive progesterone vaginal pessary for prevention of preterm delivery in twins pregnancy
Tonics groupDrug
Also called Placepo
Those patients will receive only tonics
| Study group | Role | What they receive |
|---|---|---|
| The progesterone vaginal pessary group | Active comparator | Where they will have progesterone vaginal pessary (Prontogest 400 mg) daily at bed time from 28 weeks of pregnancy till delivery in addition to tonic and calcium Receives: Drug: The progesterone vaginal pessary |
| Tonics group | Placebo comparator | Where they will receive only tonics and calcium from 28 weeks of pregnancy till delivery Receives: Drug: Tonics group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of delivery
Measured: from 28 weeks till delivery
Secondary outcomes (3)
Mode of delivery
Measured: from 28 weeks till delivery
Birth weight
Measured: at time of delivery
The need for neonatal intensive care incubator.
Measured: after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study start1 Feb 2014
- Primary completion1 Jan 2017
- Study completion15 Jan 2017
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.
- More trials run by Assiut 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Sohag University
- Responsible party
- Principal investigator, Omar Mamdouh Shaaban, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350231
- Sponsor's protocol ID
- Progesterone vaginal pessary
- Acronym
- PPPTP
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2015
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth
- ClinicalTrials.gov ID
- NCT02350231
- Acronym / sponsor ID
- PPPTP / Progesterone vaginal pessary
- Conditions
- Preterm Birth
- Keywords
- preterm birth, Twin pregnancy, progesterone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Sohag University
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 29 Jan 2015 (estimated)
- 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.
Multiple pregnancies accounted for 1 - 6 % of all births in UK during 2007. More than 98% of these multiple births being twin births . Preterm birth defined as birth occurring prior to 37 weeks of gestation and it was about 15 % of pregnancies in developed world and 12.7 % in the United States.
Preterm birth is the leading cause of infant and neonatal mortality. Premature neonates are at increased risk of developing respiratory distress syndrome, sepsis, intraventricular hemorrhage, and necrotizing enterocolitis.
Twin pregnancy is considered one of the important risk factors of preterm birth. Over distension of uterus may be one of the etiological factors for preterm birth. However, no definite effective interventions have been shown to prevent preterm delivery in twin pregnancy.
Three large randomized trials suggested that progesterone might prevent preterm delivery in high-risk singleton pregnancy especially those with previous preterm delivery or short cervix might be reduced by antenatal progesterone.
Fonseca et al (2007) concluded that women with short cervix are less likely to deliver preterm ≤34 weeks if they are treated with vaginal progesterone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The progesterone vaginal pessary group | Active comparator | Drug: The progesterone vaginal pessaryWhere they will have progesterone vaginal pessary (Prontogest 400 mg) daily at bed time from 28 weeks of pregnancy till delivery in addition to tonic and calcium |
| Tonics group | Placebo comparator | Drug: Tonics groupWhere they will receive only tonics and calcium from 28 weeks of pregnancy till delivery |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diamniotic twin pregnancy
- Gestational age ± 28 weeks.
Key exclusion criteria (11 listed)
- Higher multiple pregnancy
- IUFD of one or both fetuses
- Any congenital anomalies
- IUGR or discordant twins
- PROM
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 |
|---|---|---|
| The progesterone vaginal pessaryAlso: Active drug treatmentThose patients will receive progesterone vaginal pessary for prevention of preterm delivery in twins pregnancy | Drug | The progesterone vaginal pessary group |
| Tonics groupAlso: PlacepoThose patients will receive only tonics | Drug | Tonics group |
Primary outcome
Time of delivery
Time frame: from 28 weeks till delivery
3 secondary outcomes
Mode of delivery
Time frame: from 28 weeks till delivery
Birth weight
Time frame: at time of delivery
The need for neonatal intensive care incubator.
Time frame: after delivery
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 24 Jan 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing The progesterone vaginal pessary and Tonics group in people with Preterm Birth, run by Assiut University.
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 2 inclusion and 11 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time of delivery (time frame: from 28 weeks till delivery). 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 24 Jan 2017.