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Vasa PreviaFLUMENNCT06290232

Fetoscopic Laser Photocoagulation in Management of Vasa Previa

A study testing Fetoscopic Laser Photocoagulation in people with Vasa Previa and Pregnancy Complications, run by Boston Children's Hospital at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In this research study, the investigators want to learn more about the safety and effectiveness of a fetal surgery, known as fetoscopic laser photocoagulation (FLP), for the treatment of a pregnancy condition called vasa previa (VP). Read more about this study

Who is it for?
Ages 18 to 55 years, women only
What is being tested?
Fetoscopic Laser Photocoagulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Dec 2026to 31 Mar 2028
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 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Pregnant patient
  • Singleton pregnancy
  • Confirmed diagnosis of vasa previa, defined as unprotected fetal vessels running through the membranes at or within 5cm of the internal cervical os. Diagnosis must be confirmed after 26w0d, and before 32w5d
  • Able to undergo intervention during 30w0d to 32w6d
  • Type II vasa previa in which one placental lobe is considered to be accessory, defined as constituting less than 20% of the total placental mass seen on MRI and US imaging
  • Type II vasa previa in which multiple bridging vessels connect the two placental lobes (≥4 vessels), and only 1-2 vessel(s) run through or within 5cm of the internal cervical os
  • Patient is eligible to undergo anesthesia
  • Patient and biological father of the fetus (if available) are able to provide signed informed consent

Who cannot join

  • Gestational age at referral higher than 32w6d
  • Multiple pregnancy
  • Vasa previa types I and III
  • Type II vasa previa in which the accessory lobe constitutes more than 20% of the total placental mass, as determined by the fetal surgeon during diagnostic fetoscopy
  • Type II vasa previa in which all of the bridging vessels between placental lobes are running over the internal cervical os
  • Fetal growth restriction, defined as estimated fetal weight or abdominal circumference less than the 10th percentile for gestational age
Show all 17Show fewer
  • Abnormal fetal brain MRI, including delayed maturation, hemorrhage, arterial ischemic injury, abnormal ventricular size, or any congenital anomalies
  • Allergy or previous adverse reaction to ancillary medications with no available alternative
  • Preterm contractions and PPROM before surgery
  • Preeclampsia or uterine anomaly during the current pregnancy
  • Placenta previa, low-lying placenta, placenta accreta spectrum disorder
  • Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life
  • Maternal pre-pregnancy BMI >40
  • Active hepatitis B, hepatitis C, or HIV infection
  • High risk for congenital fetal bleeding disorders
  • Unreliable pregnancy dating due to an irregular menstrual cycle/uncertain last menstrual period with no confirmed dating from first trimester ultrasound
  • The surgeon determines that the procedure is not feasible for any other reason after diagnostic fetoscopy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Fetoscopic Laser Photocoagulation in Management of Vasa Previa - FLUMEN Study

In this research study, the investigators want to learn more about the safety and effectiveness of a fetal surgery, known as fetoscopic laser photocoagulation (FLP), for the treatment of a pregnancy condition called vasa previa (VP). Vasa previa is a pregnancy complication that happens when blood vessels from the fetus grow over the entrance to the womb. In a VP pregnancy, natural vaginal birth is deadly for the baby in more than half of cases due to the bursting of VP vessels and severe blood loss. Currently, VP patients are recommended to be closely monitored and often hospitalized once they reach the third trimester of pregnancy. An early delivery by C-section would typically be performed in order to avoid breaking the exposed fetal vessels.

Fetoscopic laser photocoagulation is a minimally invasive surgery in the womb to remove or correct abnormal blood vessels and tissues. In the FLP procedure, the surgeon uses a fetoscope (a tiny telescope) and a laser device to seal off unprotected vessels. While this surgery has been used to treat other pregnancy conditions, it has not yet been proven to be safe and/or effective for the treatment of vasa previa. This treatment aims to eliminate the VP, and, if successful, may have the potential to minimize the risk of bleeding, thereby enabling patients to avoid long hospitalization before delivery. This procedure may enable VP patients to have a vaginal delivery instead of C-section.

Being tested
Fetoscopic Laser Photocoagulation
Keywords
Fetoscope, Fetoscopic Laser Photocoagulation, Low-Lying Fetal Vessels
Medical subject headings
Vasa Previa, Pregnancy Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fetoscopic Laser PhotocoagulationDevice

    Also called Fetoscopic Laser Ablation

    Pregnant patients diagnosed with type II vasa previa will undergo fetoscopic laser photocoagulation of the involved fetal vessels. FLP will be performed laparoscopically using a fetoscope (tiny telescope) and a laser device inside of the womb. This procedure will be completed at 30w0d to 32w6d gestational age.

Study groups in NCT06290232
Study groupRoleWhat they receive
Fetoscopic Laser Photocoagulation SurgeryExperimentalPregnant individuals diagnosed with type II vasa previa will undergo fetoscopic laser photocoagulation.
Receives: Device: Fetoscopic Laser Photocoagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mode of delivery

    The type of delivery, categorized as vaginal, assisted vaginal, or cesarean section.

    Measured: When the last (20th) participant reaches delivery, a little more than 3 years from study start date

  2. Gestational age at delivery

    The duration of pregnancy, measured in completed [weeks + days] from the first day of the last menstrual period (in individuals with regular menses and reliable dating) or determined through first-trimester ultrasound using fetal biometric measurements.

    Measured: When the last (20th) participant reaches delivery, a little more than 3 years from study start date

  3. Successful visualization and mapping of vasa previa

    Confirmation by the performing surgeon that the visualization and mapping of vasa previa by diagnostic fetoscopy matches imaging from US and MRI.

    Measured: When the last (20th) participant undergoes FLP surgery, about 3 years from study start date.

  4. The rate of successful coagulation of the vasa previa - intraoperative imaging

    Confirmation of the complete coagulation of the vasa previa including the absence of blood flow in involved vessels. This will be measured in the OR directly after FLP surgery by ultrasound.

    Measured: When the last (20th) participant undergoes FLP surgery, about 3 years from study start date.

  5. The rate of successful coagulation of the vasa previa - postoperative imaging

    Confirmation of the complete coagulation of the vasa previa including the absence of blood flow in involved vessels. This will be measured 2 weeks post-surgery by ultrasound and MRI.

    Measured: Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date.

  6. The rate of successful coagulation of the vasa previa - pathology

    Confirmation of the complete coagulation of the vasa previa including the absence of blood flow in involved vessels. This will be measured after delivery during placental analysis by pathology.

    Measured: When the last (20th) participant reaches delivery, a little more than 3 years from study start date

  7. Placental function

    Successful maintenance of placental function after surgery. This will be measured by MRI 2 weeks after surgery.

    Measured: Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date.

Secondary outcomes (17)

  1. GA at hospital admission

    The gestational age at hospital admission before birth.

    Measured: When the last (20th) participant is admitted to the hospital, a little less than 3 years from study start date

  2. Duration of hospital stay

    The length of hospital stay for the pregnant person will be recorded, from the time of admission to discharge.

    Measured: When the last (20th) participant is discharged from the hospital, a little more than 3 years from study start date

  3. Cause for hospital admission

    The reason for hospital admission before birth will be recorded.

    Measured: When the last (20th) participant is admitted to the hospital, a little less than 3 years from study start date

  4. The rate of spontaneous preterm labor

    The incidence of labor occurring naturally before 37 completed weeks of pregnancy with regular uterine contractions and progressive cervical dilation in the absence of medical or obstetric intervention.

    Measured: When the last (20th) participant reaches delivery, a little more than 3 years from study start date

  5. The rate of preterm premature rupture of membranes (PPROM)

    The incidence of PPROM, defined as rupture of the amniotic sac after FLP surgery and before 37 completed weeks of pregnancy.

    Measured: When the last (20th) participant reaches delivery, a little more than 3 years from study start date

  6. The rate of placental abruption

    The rate of separation of the placenta from the uterine wall after FLP surgery and before delivery.

    Measured: When the last (20th) participant reaches delivery, a little more than 3 years from study start date

  7. The rate of chorioamnionitis

    The rate of infection of the fetal membranes and amniotic fluid after FLP surgery and before delivery.

    Measured: When the last (20th) participant reaches delivery, a little more than 3 years from study start date

  8. The rate of chorioamniotic separation

    The rate of separation of the amniotic and chorionic membranes after FLP surgery and before delivery.

    Measured: When the last (20th) participant reaches delivery, a little more than 3 years from study start date

  9. Interval from procedure to delivery

    The length of time from FLP surgery to delivery will be recorded in weeks and days.

    Measured: When the last (20th) participant reaches delivery, a little more than 3 years from study start date

  10. The rate of fetal growth restriction

    The rate of fetal growth restriction, defined as an estimated fetal weight or abdominal circumference below the 10th percentile for gestational age, at any time after FLP surgery up to delivery.

    Measured: When the last (20th) participant reaches delivery, a little more than 3 years from study start date

  11. Fetal brain structure

    Normal or abnormal fetal brain structure will be assessed by MRI 2 weeks after surgery.

    Measured: Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date

  12. The rate of NICU admission

    The rate of NICU admission after birth will be recorded

    Measured: When the last (20th) participant reaches delivery, a little more than 3 years from study start date

  13. NICU length of stay

    The number of days that the baby spends in the NICU after birth.

    Measured: When the last baby is discharged from the NICU, a little more than 3 years from study start date

  14. Short term neonatal morbidity

    The rate of short term morbidity during the first 30 days of life or until hospital discharge, whichever is latest. Short-term morbidity includes neurological problems, gastrointestinal problems, respiratory problems, infections, and other problems associated with prematurity including but not limited to: necrotizing enterocolitis, bronchopulmonary dysplasia, respiratory distress syndrome, neonatal sepsis, neonatal intensive care unit admission and need for extracorporeal membrane oxygenation (ECMO).

    Measured: When the last baby is discharged from the hospital, a little more than 3 years from study start date

  15. Neonatal survival

    The rate of neonates surviving to 30 days of age, or hospital discharge, whichever is latest.

    Measured: When the last baby is discharged from the hospital, a little more than 3 years from study start date

  16. Maternal mental health score

    The Postpartum Depression Screening Scale (PDSS) - Antenatal Version will be used to assess and compare the levels of depression and anxiety before and after FLP surgery. This assessment will be given once before surgery, and once again 4-8 weeks later (at least 2 weeks after surgery).

    Measured: Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date

  17. Postnatal examination of the placenta

    The placenta will be examined for disrupted or ruptured vessels after dye staining. Secondary changes in the accessory lobe will also be checked, which are features resulting from cessation of blood supply due to prior ablation. These could include fibrin deposition, evidence of hypoxia in the chorionic villi, eventual necrosis, and parenchymal atrophy

    Measured: When the last (20th) participant reaches delivery, a little more than 3 years from study start date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2024
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Why it stopped: The Primary Investigator for this study has departed this institution. Other investigators at this institution were not interested in proceeding with this study.

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06290232
Sponsor's protocol ID
IRB-P00044498
Acronym
FLUMEN
Status last verified
Apr 2026
First submitted
26 Feb 2024
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Oyelese KO, Turner M, Lees C, Campbell S. Vasa previa: an avoidable obstetric tragedy. Obstet Gynecol Surv. 1999 Feb;54(2):138-45. doi: 10.1097/00006254-199902000-00024.

    PubMed 9950006

  • Pavalagantharajah S, Villani LA, D'Souza R. Vasa previa and associated risk factors: a systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100117. doi: 10.1016/j.ajogmf.2020.100117. Epub 2020 Apr 15.

    PubMed 33345868

  • Zhang W, Giacchino T, Chanyarungrojn PA, Ionescu O, Akolekar R. Incidence of vasa praevia: a systematic review and meta-analysis. BMJ Open. 2023 Sep 20;13(9):e075245. doi: 10.1136/bmjopen-2023-075245.

    PubMed 37730391

  • Oyelese Y, Chavez MR, Yeo L, Giannina G, Kontopoulos EV, Smulian JC, Scorza WE. Three-dimensional sonographic diagnosis of vasa previa. Ultrasound Obstet Gynecol. 2004 Aug;24(2):211-5. doi: 10.1002/uog.1097. No abstract available.

    PubMed 15287065

  • Silver RM. Vasa praevia: improved diagnosis through recognition of risk factors. BJOG. 2016 Jul;123(8):1288. doi: 10.1111/1471-0528.13870. Epub 2016 Feb 5. No abstract available.

    PubMed 26846196

  • Oyelese Y, Smulian JC. Placenta previa, placenta accreta, and vasa previa. Obstet Gynecol. 2006 Apr;107(4):927-41. doi: 10.1097/01.AOG.0000207559.15715.98.

    PubMed 16582134

  • Zhang W, Geris S, Al-Emara N, Ramadan G, Sotiriadis A, Akolekar R. Perinatal outcome of pregnancies with prenatal diagnosis of vasa previa: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2021 May;57(5):710-719. doi: 10.1002/uog.22166.

    PubMed 32735754

  • Ranzini AC, Oyelese Y. How to screen for vasa previa. Ultrasound Obstet Gynecol. 2021 May;57(5):720-725. doi: 10.1002/uog.23520. No abstract available.

    PubMed 33085148

  • Oyelese Y. Re: Incidence of and risk factors for vasa praevia: a systematic review: Vasa praevia screening. BJOG. 2017 Jan;124(1):162. doi: 10.1111/1471-0528.14013. No abstract available.

    PubMed 28009122

  • Society of Maternal-Fetal (SMFM) Publications Committee; Sinkey RG, Odibo AO, Dashe JS. #37: Diagnosis and management of vasa previa. Am J Obstet Gynecol. 2015 Nov;213(5):615-9. doi: 10.1016/j.ajog.2015.08.031. Epub 2015 Aug 18.

    PubMed 26292048

  • Jain V, Gagnon R. Guideline No. 439: Diagnosis and Management of Vasa Previa. J Obstet Gynaecol Can. 2023 Jul;45(7):506-518. doi: 10.1016/j.jogc.2023.05.009. Epub 2023 May 18.

    PubMed 37209787

  • Oyelese Y. Prenatally Diagnosed Vasa Previa: A Single-Institution Series of 96 Cases. Obstet Gynecol. 2017 Mar;129(3):581-582. doi: 10.1097/AOG.0000000000001919. No abstract available.

    PubMed 28225412

  • Klahr R, Fox NS, Zafman K, Hill MB, Connolly CT, Rebarber A. Frequency of spontaneous resolution of vasa previa with advancing gestational age. Am J Obstet Gynecol. 2019 Dec;221(6):646.e1-646.e7. doi: 10.1016/j.ajog.2019.06.040. Epub 2019 Jun 21.

    PubMed 31233708

  • Bronsteen R, Whitten A, Balasubramanian M, Lee W, Lorenz R, Redman M, Goncalves L, Seubert D, Bauer S, Comstock C. Vasa previa: clinical presentations, outcomes, and implications for management. Obstet Gynecol. 2013 Aug;122(2 Pt 1):352-357. doi: 10.1097/AOG.0b013e31829cac58.

    PubMed 23969805

  • Westcott JM, Simpson S, Chasen S, Vieira L, Stone J, Doulaveris G, Dar P, Bernstein PS, Atallah F, Dolin CD, Roman AS. Prenatally diagnosed vasa previa: association with adverse obstetrical and neonatal outcomes. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100206. doi: 10.1016/j.ajogmf.2020.100206. Epub 2020 Aug 15.

    PubMed 33345921

Questions about this trial

What is this clinical trial studying?

A study testing Fetoscopic Laser Photocoagulation in people with Vasa Previa and Pregnancy Complications, run by Boston Children's Hospital 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 8 inclusion and 17 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 2 Jun 2026. 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. 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?

Mode of delivery (time frame: When the last (20th) participant reaches delivery, a little more than 3 years from study start date). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06290232, which also lists 58 linked publications.

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 2 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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