Morbidly Adherent PlacentaMAPNCT02635412
Delivery Timing in Morbidly Adherent Placentas: a Randomized, Controlled Trial
A study testing Scheduled timing of delivery in people with Morbidly Adherent Placenta and Placenta Accreta, run by The University of Texas Health Science Center, Houston.
Trial summary
This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Morbidly Adherent Placenta, Placenta Accreta
- What is being tested?
- Scheduled timing of delivery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2018
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with monographically morbidly adherent placenta with or without a placenta previa.
- Scheduled delivery via cesarean hysterectomy
Who cannot join
- Delivery planned prior to 36 weeks (e.g. non-reassuring fetal status, preterm labor, severe preeclampsia, other medical/fetal indication for delivery as determined by the managing physician).
About this study
This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta.
Read the detailed description
This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta dispositioned for a scheduled delivery. The primary outcome will be assessed by comparing the composite neonatal morbidity and composite maternal morbidity between the two groups (delivery at 34 versus 36 weeks gestational age).
- Conditions
- Morbidly Adherent Placenta, Placenta Accreta
- Being tested
- Scheduled timing of delivery
- Keywords
- Placenta, Accreta, Morbidly, Adherent Placenta
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled timing of deliveryOther
| Study group | Role | What they receive |
|---|---|---|
| Scheduled delivery at 34 weeks | Placebo comparator | Scheduled delivery at 34 weeks (range 33 weeks 5 days to 34 weeks 3 days) Receives: Other: Scheduled timing of delivery |
| Scheduled delivery at 36 weeks | Active comparator | Scheduled delivery at 36 weeks (range 35 weeks 5 days to 36 weeks 3 days) Receives: Other: Scheduled timing of delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite neonatal morbidity
Measured: Within 72 hours of newborn discharge
Maternal neonatal morbidity
Measured: Within 72 hours of patient discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: Never approved by the IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbidly Adherent PlacentaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635412
- Sponsor's protocol ID
- HSC-MS-16-0085
- Acronym
- MAP
- Status last verified
- Jul 2018
- First submitted
- 16 Dec 2015
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery Timing in Morbidly Adherent Placentas: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02635412
- Acronym / sponsor ID
- MAP / HSC-MS-16-0085
- Conditions
- Morbidly Adherent Placenta, Placenta Accreta
- Keywords
- Placenta, Accreta, Morbidly, Adherent Placenta
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never approved by the IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 18 Dec 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.
This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta.
Detailed description
This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta dispositioned for a scheduled delivery. The primary outcome will be assessed by comparing the composite neonatal morbidity and composite maternal morbidity between the two groups (delivery at 34 versus 36 weeks gestational age).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scheduled delivery at 34 weeks | Placebo comparator | Other: Scheduled timing of deliveryScheduled delivery at 34 weeks (range 33 weeks 5 days to 34 weeks 3 days) |
| Scheduled delivery at 36 weeks | Active comparator | Other: Scheduled timing of deliveryScheduled delivery at 36 weeks (range 35 weeks 5 days to 36 weeks 3 days) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women with monographically morbidly adherent placenta with or without a placenta previa.
- Scheduled delivery via cesarean hysterectomy
Key exclusion criteria (1 listed)
- Delivery planned prior to 36 weeks (e.g. non-reassuring fetal status, preterm labor, severe preeclampsia, other medical/fetal indication for delivery as determined by the managing physician).
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 |
|---|---|---|
| Scheduled timing of delivery | Other | Scheduled delivery at 34 weeks, Scheduled delivery at 36 weeks |
Primary outcome
Composite neonatal morbidity
Time frame: Within 72 hours of newborn discharge
Maternal neonatal morbidity
Time frame: Within 72 hours of patient discharge
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 6 Jul 2018.
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 study testing Scheduled timing of delivery in people with Morbidly Adherent Placenta and Placenta Accreta, run by The University of Texas Health Science Center, Houston.
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 1 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 6 Jul 2018. 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.
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?
Composite neonatal morbidity (time frame: Within 72 hours of newborn discharge). 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 6 Jul 2018; AzTrials last refreshed its copy on 31 Oct 2026.