Premature BirthPhase 2/3NCT01812239
Vaginal Progesterone in Twins With Short Cervix
A Phase 2/3 study testing Vaginal Progesterone gel. and fetal fibronectin swab. in people with Premature Birth, run by Obstetrix Medical Group at 1 site in United States.
Trial summary
A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Vaginal Progesterone gel. and fetal fibronectin swab.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Aug 2018
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gestational age between 20w0d and 24w0d
- Twin pregnancy, diamniotic-dichorionic, both twins living
- Cervical length 10 mm to 25 mm discovered by a screening transvaginal ultrasound exam
Who cannot join
- Mother less than 18 years of age
- Uterine contractions of 40 seconds duration or more, 10 or more per hour
- Rupture of fetal membranes (leakage of amniotic fluid one or both sacs)
- Ongoing vaginal bleeding
- Any condition likely to cause serious neonatal morbidity independent of gestational age, including:
- fetal malformation likely to require surgery
Show all 19Show fewer
- fetal malformation involving vital organs
- fetal viral infection
- hydrops fetalis
- discordance in estimated fetal weight more than 10%
- velamentous insertion of umbilical cord of either twin
- placenta previa of either placenta
- Any contraindication to continuing the pregnancy
- Cervical cerclage in place or planned
- Any contraindication to vaginal micronized progesterone, including:
- Known sensitivity to progesterone or any of the other ingredients
- Liver dysfunction or disease
- Known or suspected malignancy of breast or genital organs
- Active thromboembolic disorder, or history of hormone-associated thromboembolic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy With Short Cervix. Double-Blind, Placebo-Controlled, Randomized Clinical Trial
A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.
Read the detailed description
This is a placebo-controlled, double-blind, randomized clinical trial of asymptomatic women with twin pregnancy and a cervix length 10 mm to 25 mm discovered on a routine screening transvaginal sonogram between 20w0d to 24w0d gestational age. Women will be randomized in either the in-patient or out-patient setting (1:1) to a daily vaginal application of micronized progesterone cream(200 mg)vs. placebo to determine if daily vaginal progesterone administration reduces the risk of preterm birth prior to 34w0d of gestation.
- Conditions
- Premature Birth
- Being tested
- Vaginal Progesterone gel., fetal fibronectin swab., Placebo gel
- Keywords
- premature birth, twins, short cervix
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Progesterone gel.Drug
Also called progestin
Daily administration of Vaginal Progesterone gel in pregnant women with twins between the 20th week of pregnancy and the 34th week of pregnancy.
fetal fibronectin swab.Procedure or surgery
Also called fFN, fibronectin
Collection of quantatative fetal fibronectin swab one week after randomization into the trial for both arms. Randomziation occurs between 20 weeks - 24 weeks of gestation.
Placebo gelDrug
Also called placebo
weekly vaginal administration of the placebo gel from randomization until 34 weeks of gestation.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Progesterone | Active comparator | Daily administration of Vaginal Progesterone (200mg) Gel between 20 weeks of pregnancy and 34 weeks of pregnancy. Receives: Drug: Vaginal Progesterone gel.; Procedure: fetal fibronectin swab. |
| Placebo | Placebo comparator | Daily vaginal administration of Placebo gel (Vanicream)between 20 weeks of pregnancy and 34 weeks of pregnancy. Receives: Procedure: fetal fibronectin swab.; Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth of baby before 34 weeks of gestation
The primary outcome is defined as Early Preterm Birth, that is, birth before 34weeks of gestation. A birth at 33weeks 6days or earlier is considered to have the primary outcome. A birth at 34weeks 0days or later does not have the primary outcome. Births for any reason before 34weeks 0days are considered to have the primary outcome, whether they are "spontaneous" or not.
Measured: At the time of delivery
Secondary outcomes (3)
Gestational age of baby at birth
measured of the average Gestational age of babies at birth.
Measured: measure at time of birth
Rate of "spontaneous birth" before 34weeks of gestation
Rate of "spontaneous birth" before 34weeks of gestation. Spontaneous births are those whose underlying cause is judged to be due to preterm labor, prelabor rupture of membranes, or cervical insufficiency. (In contradistinction, "indicated" deliveries are those due to preeclampsia, fetal growth problems, fetal heart rate abnormalities, and other problems.)
Measured: from randomization to birth of the baby - up to 15 weeks
Rate of composite neonatal morbidity
Composite morbidity is defined as any one or more of: stillbirth, neonatal death, infant death before hospital discharge, respiratory distress syndrome (RDS), intracranial hemorrhage (grade 3 or 4)(IVH), necrotizing enterocolitis (stage 2 or 3)(NEC), documented neonatal sepsis within 72 hr of birth, or periventricular leukomalacia (characteristic lesions in the subcortical white matter seen on cerebral imaging studies within 96 hrs of birth)(PVL).
Measured: measures from randomization to 60 days post delivery of the baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startMar 2014
- Primary completionAug 2017 (estimated)
- Study completionAug 2018 (estimated)
Why it stopped: inability to retain study drug with comparable placebo.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obstetrix Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Combs, MD, Principal investigator, Pediatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812239
- Sponsor's protocol ID
- OBX0019
- Status last verified
- Dec 2014
- First submitted
- 12 Mar 2013
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy With Short Cervix. Double-Blind, Placebo-Controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01812239
- Acronym / sponsor ID
- OBX0019
- Conditions
- Premature Birth
- Keywords
- premature birth, twins, short cervix
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: inability to retain study drug with comparable placebo.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Obstetrix Medical GroupIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 18 Mar 2013 (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.
A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.
Detailed description
This is a placebo-controlled, double-blind, randomized clinical trial of asymptomatic women with twin pregnancy and a cervix length 10 mm to 25 mm discovered on a routine screening transvaginal sonogram between 20w0d to 24w0d gestational age. Women will be randomized in either the in-patient or out-patient setting (1:1) to a daily vaginal application of micronized progesterone cream(200 mg)vs. placebo to determine if daily vaginal progesterone administration reduces the risk of preterm birth prior to 34w0d of gestation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Progesterone | Active comparator | Drug: Vaginal Progesterone gel., Procedure: fetal fibronectin swab.Daily administration of Vaginal Progesterone (200mg) Gel between 20 weeks of pregnancy and 34 weeks of pregnancy. |
| Placebo | Placebo comparator | Procedure: fetal fibronectin swab., Drug: Placebo gelDaily vaginal administration of Placebo gel (Vanicream)between 20 weeks of pregnancy and 34 weeks of pregnancy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Gestational age between 20w0d and 24w0d
- Twin pregnancy, diamniotic-dichorionic, both twins living
- Cervical length 10 mm to 25 mm discovered by a screening transvaginal ultrasound exam
Key exclusion criteria (19 listed)
- Mother less than 18 years of age
- Uterine contractions of 40 seconds duration or more, 10 or more per hour
- Rupture of fetal membranes (leakage of amniotic fluid one or both sacs)
- Ongoing vaginal bleeding
- Any condition likely to cause serious neonatal morbidity independent of gestational age, including:
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 |
|---|---|---|
| Vaginal Progesterone gel.Also: progestinDaily administration of Vaginal Progesterone gel in pregnant women with twins between the 20th week of pregnancy and the 34th week of pregnancy. | Drug | Vaginal Progesterone |
| fetal fibronectin swab.Also: fFN, fibronectinCollection of quantatative fetal fibronectin swab one week after randomization into the trial for both arms. Randomziation occurs between 20 weeks - 24 weeks of gestation. | Procedure or surgery | Placebo, Vaginal Progesterone |
| Placebo gelAlso: placeboweekly vaginal administration of the placebo gel from randomization until 34 weeks of gestation. | Drug | Placebo |
Primary outcome
Birth of baby before 34 weeks of gestation
Time frame: At the time of delivery
The primary outcome is defined as Early Preterm Birth, that is, birth before 34weeks of gestation. A birth at 33weeks 6days or earlier is considered to have the primary outcome. A birth at 34weeks 0days or later does not have the primary outcome. Births for any reason before 34weeks 0days are considered to have the primary outcome, whether they are "spontaneous" or not.
3 secondary outcomes
Gestational age of baby at birth
Time frame: measure at time of birth
Rate of "spontaneous birth" before 34weeks of gestation
Time frame: from randomization to birth of the baby - up to 15 weeks
Rate of composite neonatal morbidity
Time frame: measures from randomization to 60 days post delivery of the baby
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
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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.
Andrew Combs, MD principal investigator
Pediatrix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vaginal Progesterone gel. and fetal fibronectin swab. in people with Premature Birth, run by Obstetrix Medical Group at 1 site in United States.
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 19 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: withdrawn, as of the sponsor's last update on 19 Dec 2014. 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 United States. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Birth of baby before 34 weeks of gestation (time frame: At the time of 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 19 Dec 2014.