MyelomeningoceleNCT03073382
Risk Factors Associated With Spontaneous Preterm Delivery Status Post Open Fetal Myelomeningocele Repair
An observational study of Myelomeningocele, run by University of Nebraska.
Trial summary
This is a chart review of all patients who have underwent open prenatal repair of fetal myelomeningocele. Although prenatal repair is associated with improved neurologic outcomes and a decreased need for cerebrospinal fluid shunting after birth, one of the major risks is preterm delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Myelomeningocele
- What is being tested?
- Chart review
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 26 May 2017
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: patients who underwent open fetal myelomeningocele repair Ethnicity: Any
Who may be able to join
- chart review of all patients who have underwent open prenatal repair of fetal myelomeningocele.
Who cannot join
- excluded if delivery information is unavailable.
About this study
This is a chart review of all patients who have underwent open prenatal repair of fetal myelomeningocele. Although prenatal repair is associated with improved neurologic outcomes and a decreased need for cerebrospinal fluid shunting after birth, one of the major risks is preterm delivery. This study is intended to identify maternal, fetal or intraoperative risk factors associated with preterm delivery.
Read the detailed description
Myelomeningocele encompasses the most common form of spina bifida. The incidence ranges from 2.73-3.80 per 10,000 births in the United States. The extent of neurologic sequela is correlated with the level of the lesion but frequently involves a spectrum of motor dysfunction including paralysis of the lower extremities, contractures in addition to lack of bladder and bowel control. These result in significant lifestyle limitations for survivors. Additionally, hydrocephalus, brainstem herniation and Chiari II malformations are commonly noted. Ventriculoperitoneal shunts are commonly placed in childhood to redirect cerebrospinal fluid and can require revisions later in life.
The Management of Myelomeningocele Study (MOMS) trial revolutionized management of fetuses with myelomeningoceles by demonstrating that prenatal compared to standard postnatal repair resulted in decreased need for cerebrospinal fluid shunts and improved motor function at thirty months. As a result, various centers around the United States began offering prenatal repair to patients less than twenty-six weeks gestation with prespecified maternal and fetal characteristics.
Prenatal repair is not without risk to both the mother and the fetus. The mother must undergo a laparotomy and accept the risks involved with any intraabdominal surgery including bleeding, infection, adhesion formation and damage to nearby organs. Unique to this procedure, a hysterotomy is typically created in the active segment of the uterus to allow for sufficient exposure of the fetal lesion. Like those women who undergo classical Cesarean sections, these patients must undergo Cesarean sections around 37 weeks gestation for all future pregnancies secondary to concern of uterine dehiscence in the setting of labor. This has major implications for the mother's future childbearing potential, as the number of previous Cesarean sections increases the risk of intraoperative complications and invasive placentation in subsequent pregnancies. A fetoscopic approach has reemerged in the United States as an alternative to the aforementioned open approach and is currently under further investigation.
Intraoperative fetal distress has been reported and can lead to loss of the pregnancy. Additionally, fetal surgery carries the risks of spontaneous preterm birth and preterm premature rupture of membranes, which subject the fetus to the morbidity of prematurity. This risk of spontaneous preterm delivery is one of the more common and significant drawbacks to the procedure and represents a major hurdle to overcome. In the MOMS trial, 46% of those in the study group compared to 8% in the postnatal repair group experienced spontaneous rupture of membranes. Thirty-eight percent of prenatal repair versus 14% of postnatal repair patients went into spontaneous labor prior to scheduled delivery. The average gestational age at birth was 34 weeks for the prenatal surgery group and 37 weeks for the postnatal surgery group. In another study following the MOMS trial, 100 patient underwent prenatal repair with a reported 32.3% rate of preterm premature rupture of membranes(PPROM) and 37.5% rate of preterm labor. Also reported a modified surgical approach to the hysterotomy and closure among 43 patients and found a 22% rate of PPROM. Thirty-nine percent delivered at 37 weeks or later compared with 21% of the MOMS cohort.
Although the increased risk of preterm delivery is reported, little is known regarding risk factors associated with preterm delivery following this procedure. Soni et al. found that chorioamniotic membrane separation was a risk factor for subsequent PPROM. No studies have been published that assess risk factors for all spontaneous preterm deliveries including both preterm labor and PPROM. The objective of this study is to determine if any maternal, fetal or intraoperative factors can be identified that increase the risk of spontaneous preterm delivery in patients who undergo prenatal open myelomeningocele repair. With the identification of such factors, counseling of the patient and potentially patient selection could be refined in the future.
- Conditions
- Myelomeningocele
- Being tested
- Chart review
- Medical subject headings
- Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chart reviewOther
This is a chart review of all patients who have underwent open prenatal repair of fetal myelomeningocele. Although prenatal repair is associated with improved neurologic outcomes and a decreased need for cerebrospinal fluid shunting after birth, one of the major risks is preterm delivery. This study is intended to identify maternal, fetal or intraoperative risk factors associated with preterm delivery.
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of spontaneous preterm delivery
Although prenatal repair is associated with improved neurologic outcomes and a decreased need for cerebrospinal fluid shunting after birth, one of the major risks is preterm delivery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Jan 2017
- Primary completion26 May 2017
- Study completion26 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomeningoceleStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- St. Louis University
- Responsible party
- Sponsor
- Investigators
- Heather H Said, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073382
- Sponsor's protocol ID
- 26891
- Status last verified
- Dec 2023
- First submitted
- 1 Feb 2017
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Associated With Spontaneous Preterm Delivery Status Post Open Fetal Myelomeningocele Repair
- ClinicalTrials.gov ID
- NCT03073382
- Acronym / sponsor ID
- 26891
- Conditions
- Myelomeningocele
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- St. Louis University
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 26 May 2017 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 8 Mar 2017 (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 chart review of all patients who have underwent open prenatal repair of fetal myelomeningocele. Although prenatal repair is associated with improved neurologic outcomes and a decreased need for cerebrospinal fluid shunting after birth, one of the major risks is preterm delivery. This study is intended to identify maternal, fetal or intraoperative risk factors associated with preterm delivery.
Detailed description
Myelomeningocele encompasses the most common form of spina bifida. The incidence ranges from 2.73-3.80 per 10,000 births in the United States. The extent of neurologic sequela is correlated with the level of the lesion but frequently involves a spectrum of motor dysfunction including paralysis of the lower extremities, contractures in addition to lack of bladder and bowel control. These result in significant lifestyle limitations for survivors. Additionally, hydrocephalus, brainstem herniation and Chiari II malformations are commonly noted. Ventriculoperitoneal shunts are commonly placed in childhood to redirect cerebrospinal fluid and can require revisions later in life.
The Management of Myelomeningocele Study (MOMS) trial revolutionized management of fetuses with myelomeningoceles by demonstrating that prenatal compared to standard postnatal repair resulted in decreased need for cerebrospinal fluid shunts and improved motor function at thirty months. As a result, various centers around the United States began offering prenatal repair to patients less than twenty-six weeks gestation with prespecified maternal and fetal characteristics.
Prenatal repair is not without risk to both the mother and the fetus. The mother must undergo a laparotomy and accept the risks involved with any intraabdominal surgery including bleeding, infection, adhesion formation and damage to nearby organs. Unique to this procedure, a hysterotomy is typically created in the active segment of the uterus to allow for sufficient exposure of the fetal lesion. Like those women who undergo classical Cesarean sections, these patients must undergo Cesarean sections around 37 weeks gestation for all future pregnancies secondary to concern of uterine dehiscence in the setting of labor. This has major implications for the mother's future childbearing potential, as the number of previous Cesarean sections increases the risk of intraoperative complications and invasive placentation in subsequent pregnancies. A fetoscopic approach has reemerged in the United States as an alternative to the aforementioned open approach and is currently under further investigation.
Intraoperative fetal distress has been reported and can lead to loss of the pregnancy. Additionally, fetal surgery carries the risks of spontaneous preterm birth and preterm premature rupture of membranes, which subject the fetus to the morbidity of prematurity. This risk of spontaneous preterm delivery is one of the more common and significant drawbacks to the procedure and represents a major hurdle to overcome. In the MOMS trial, 46% of those in the study group compared to 8% in the postnatal repair group experienced spontaneous rupture of membranes. Thirty-eight percent of prenatal repair versus 14% of postnatal repair patients went into spontaneous labor prior to scheduled delivery. The average gestational age at birth was 34 weeks for the prenatal surgery group and 37 weeks for the postnatal surgery group. In another study following the MOMS trial, 100 patient underwent prenatal repair with a reported 32.3% rate of preterm premature rupture of membranes(PPROM) and 37.5% rate of preterm labor. Also reported a modified surgical approach to the hysterotomy and closure among 43 patients and found a 22% rate of PPROM. Thirty-nine percent delivered at 37 weeks or later compared with 21% of the MOMS cohort.
Although the increased risk of preterm delivery is reported, little is known regarding risk factors associated with preterm delivery following this procedure. Soni et al. found that chorioamniotic membrane separation was a risk factor for subsequent PPROM. No studies have been published that assess risk factors for all spontaneous preterm deliveries including both preterm labor and PPROM. The objective of this study is to determine if any maternal, fetal or intraoperative factors can be identified that increase the risk of spontaneous preterm delivery in patients who undergo prenatal open myelomeningocele repair. With the identification of such factors, counseling of the patient and potentially patient selection could be refined in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients who underwent open fetal myelomeningocele repair Ethnicity: Any
Key inclusion criteria (1 listed)
- chart review of all patients who have underwent open prenatal repair of fetal myelomeningocele.
Key exclusion criteria (1 listed)
- excluded if delivery information is unavailable.
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 |
|---|---|---|
| Chart reviewThis is a chart review of all patients who have underwent open prenatal repair of fetal myelomeningocele. Although prenatal repair is associated with improved neurologic outcomes and a decreased need for cerebrospinal fluid shunting after birth, one of the major risks is preterm delivery. This study is intended to identify maternal, fetal or intraoperative risk factors associated with preterm delivery. | Other | – |
Primary outcome
The number of spontaneous preterm delivery
Time frame: 1 year
Although prenatal repair is associated with improved neurologic outcomes and a decreased need for cerebrospinal fluid shunting after birth, one of the major risks is preterm 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 3 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.
Heather H Said, MD principal investigator
St. Louis University
Questions about this trial
What is this clinical trial studying?
An observational study of Myelomeningocele, run by University of Nebraska.
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 1 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: finished, as of the sponsor's last update on 3 Jan 2024. 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. 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?
The number of spontaneous preterm delivery (time frame: 1 year). 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 3 Jan 2024.