Blood and Blood DisordersTTTS1NCT01220011
Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery
A study testing Fetoscopic laser surgery in people with Blood and Blood Disorders and Anemia, Neonatal, run by Assistance Publique - Hôpitaux de Paris at 11 sites in 3 countries.
Trial summary
The objective of this trial is to compare both strategies (Expectative Vs Fetoscopic laser surgery) for patients with stage 1 TTTS and favorable obstetrical parameters in an international randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Blood and Blood Disorders, Anemia, Neonatal, Hematologic Disease
- What is being tested?
- Fetoscopic laser surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 19 Apr 2011to 31 Mar 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TTTS stage 1 (Euro foetus criteria)
- Gestational age > 16 and < 26 weeks
- Age > 18
- Informed consent
Who cannot join
- Therapeutic amniocentesis prior to referral
- Short cervix < 15 mm on transvaginal US
- Severe maternal discomfort:Dyspnea and orthopnea, Abdominal pain > 4 on a 10-level visual analogic pain scale, Contractions > 1 per hour
- PPROM
- Fetal malformations unrelated to TTTS
- Follow-up is impossible
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States8 sites
Children's Hospital Colorado and Colorado Fetal Care Center
Aurora, Colorado, 80045
University of MD /Department of Obstetrics, Gynecology & Reproductive Sciences
Baltimore, Maryland, 21000
Fetal Care Center of Cincinnati, Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3026
The Ohio State University / OSU Fetal Therapy Program
Columbus, Ohio, 43221
The Texas Fetal Center, Children's Memorial Hermann Hospital, University of Texas Medical School
Houston, Texas, 77030
Fetal Therapy Program, Evergrenn Hospital Medical Center
Kirkland, Washington, 98034
Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Fetal Treatment Program of New England, Hasbro Children's Hospital, The Warren Alpert Medical School of Brown University.
Providence, Rhode Island, 02903
Canada2 sites
Hospital Ste-Justine
Montreal, Quebec, H3T 1R2
Mount Sinai Hospital, University of Toronto
Toronto, Ontario, ON M5X 1X5
About this study
Official title: A Cluster Randomized Trial Comparing a Conservative Management and Primary Laser Surgery
The objective of this trial is to compare both strategies (Expectative Vs Fetoscopic laser surgery) for patients with stage 1 TTTS and favorable obstetrical parameters in an international randomized controlled trial. This trial will answer an important question and will help in the management and tailoring of surgical indications in stage 1 TTTS.
Read the detailed description
Although we demonstrated the overall benefit of fetoscopic laser surgery as first-line treatment in twin-twin transfusion syndrome (TTTS), indications in early stage TTTS are controversial. Indeed, a conservative management with close follow-up is offered in some centers as first-line management for QUINTERO stage 1 TTTS, although this strategy has not been formally compared to first-line fetoscopic placental surgery. The objective of this trial is to compare both strategies for patients with stage 1 TTTS and favorable obstetrical parameters in an international randomized controlled trial. Patients randomized to a conservative management will be followed on a weekly basis as long as the syndrome remains stable using obstetrical and fetal parameters and until an adequate gestational age is reached allowing delivery. Cases progressing to stage ≥ 2 or with a worsening of obstetrical parameters during follow-up in this group will be actively treated by percutaneous laser coagulation. Patients allocated to the "immediate laser" group will be treated by fetoscopic laser surgery within 24 h following randomization. The primary end-point encompasses survival and neurological morbidity at the age of 6 months for each foetus randomized. Analyses and power computations use a cluster-trial methodology that accounts for the inter-twin correlation, with many benefits over more traditional designs using a per-pregnancy outcome. With proportions of 60% and 75% meaning a clinically relevant difference of 15% between the groups, 200 fetuses or equivalently 100 pregnancies would be needed in each arm to reach a power of 80% with an alpha-risk of 5%, allowing 2 interim analyses based upon LAN-DEMETS boundaries and an O'Brien-Fleming function. Inclusion criteria, interventions and randomisation were investigated through a preliminary survey across potential participating centers. Based on this survey, it is anticipated that 3 years will be needed to achieve the requested number of patients. This trial will answer an important question and will help in the management and tailoring of surgical indications in stage 1 TTTS.
- Conditions
- Blood and Blood Disorders, Anemia, Neonatal, Hematologic Disease, Infant, Newborn, Diseases
- Being tested
- Fetoscopic laser surgery
- Keywords
- Fetoscopic Laser surgery, Stage 1 Twin - twin transfusion syndrome
- Medical subject headings
- Hematologic Diseases, Anemia, Neonatal, Infant, Newborn, Diseases, Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetoscopic laser surgeryProcedure or surgery
Fetoscopic laser surgery
| Study group | Role | What they receive |
|---|---|---|
| NO INTERVENTION | Experimental | Not described Receives: Procedure: Fetoscopic laser surgery |
| fetoscopic laser | Active comparator | Not described Receives: Procedure: Fetoscopic laser surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival and neurological morbidity at the age of 6 months for each foetus randomized
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study start19 Apr 2011
- Primary completion30 Sep 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood and Blood DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Yves VILLE, PUPH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220011
- Sponsor's protocol ID
- K090601
- Other IDs
- ID RCB : 2010-A00026-33
- Acronym
- TTTS1
- Status last verified
- Feb 2026
- First submitted
- 11 Oct 2010
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Stirnemann J, Slaghekke F, Khalek N, Winer N, Johnson A, Lewi L, Massoud M, Bussieres L, Aegerter P, Hecher K, Senat MV, Ville Y. Intrauterine fetoscopic laser surgery versus expectant management in stage 1 twin-to-twin transfusion syndrome: an international randomized trial. Am J Obstet Gynecol. 2021 May;224(5):528.e1-528.e12. doi: 10.1016/j.ajog.2020.11.031. Epub 2020 Nov 26.
PubMed 33248135
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Trial Comparing a Conservative Management and Primary Laser Surgery
- ClinicalTrials.gov ID
- NCT01220011
- Acronym / sponsor ID
- TTTS1 / K090601
- Conditions
- Blood and Blood Disorders, Anemia, Neonatal, Hematologic Disease, Infant, Newborn, Diseases
- Keywords
- Fetoscopic Laser surgery, Stage 1 Twin - twin transfusion syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 19 Apr 2011 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 13 Oct 2010 (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.
The objective of this trial is to compare both strategies (Expectative Vs Fetoscopic laser surgery) for patients with stage 1 TTTS and favorable obstetrical parameters in an international randomized controlled trial. This trial will answer an important question and will help in the management and tailoring of surgical indications in stage 1 TTTS.
Detailed description
Although we demonstrated the overall benefit of fetoscopic laser surgery as first-line treatment in twin-twin transfusion syndrome (TTTS), indications in early stage TTTS are controversial. Indeed, a conservative management with close follow-up is offered in some centers as first-line management for QUINTERO stage 1 TTTS, although this strategy has not been formally compared to first-line fetoscopic placental surgery. The objective of this trial is to compare both strategies for patients with stage 1 TTTS and favorable obstetrical parameters in an international randomized controlled trial. Patients randomized to a conservative management will be followed on a weekly basis as long as the syndrome remains stable using obstetrical and fetal parameters and until an adequate gestational age is reached allowing delivery. Cases progressing to stage ≥ 2 or with a worsening of obstetrical parameters during follow-up in this group will be actively treated by percutaneous laser coagulation. Patients allocated to the "immediate laser" group will be treated by fetoscopic laser surgery within 24 h following randomization. The primary end-point encompasses survival and neurological morbidity at the age of 6 months for each foetus randomized. Analyses and power computations use a cluster-trial methodology that accounts for the inter-twin correlation, with many benefits over more traditional designs using a per-pregnancy outcome. With proportions of 60% and 75% meaning a clinically relevant difference of 15% between the groups, 200 fetuses or equivalently 100 pregnancies would be needed in each arm to reach a power of 80% with an alpha-risk of 5%, allowing 2 interim analyses based upon LAN-DEMETS boundaries and an O'Brien-Fleming function. Inclusion criteria, interventions and randomisation were investigated through a preliminary survey across potential participating centers. Based on this survey, it is anticipated that 3 years will be needed to achieve the requested number of patients. This trial will answer an important question and will help in the management and tailoring of surgical indications in stage 1 TTTS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NO INTERVENTION | Experimental | Procedure: Fetoscopic laser surgery |
| fetoscopic laser | Active comparator | Procedure: Fetoscopic laser surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- TTTS stage 1 (Euro foetus criteria)
- Gestational age > 16 and < 26 weeks
- Age > 18
- Informed consent
Key exclusion criteria (6 listed)
- Therapeutic amniocentesis prior to referral
- Short cervix < 15 mm on transvaginal US
- Severe maternal discomfort:Dyspnea and orthopnea, Abdominal pain > 4 on a 10-level visual analogic pain scale, Contractions > 1 per hour
- PPROM
- Fetal malformations unrelated to TTTS
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 |
|---|---|---|
| Fetoscopic laser surgeryFetoscopic laser surgery | Procedure or surgery | NO INTERVENTION, fetoscopic laser |
Primary outcome
survival and neurological morbidity at the age of 6 months for each foetus randomized
Time frame: 6 MONTHS
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 13 Feb 2026.
- Results publication: PubMed 33248135Stirnemann J, Slaghekke F, Khalek N, Winer N, Johnson A, Lewi L, Massoud M, Bussieres L, Aegerter P, Hecher K, Senat MV, Ville Y. Intrauterine fetoscopic laser surgery versus expectant management in stage 1 twin-to-twin transfusion syndrome: an international randomized trial. Am J Obstet Gynecol. 2021 May;224(5):528.e1-528.e12. doi: 10.1016/j.ajog.2020.11.031. Epub 2020 Nov 26.
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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.
Yves VILLE, PUPH principal investigator
Assistance Publique - Hôpitaux de Paris
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetoscopic laser surgery in people with Blood and Blood Disorders and Anemia, Neonatal, run by Assistance Publique - Hôpitaux de Paris at 11 sites in 3 countries.
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 4 inclusion and 6 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 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada, France. 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 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?
survival and neurological morbidity at the age of 6 months for each foetus randomized (time frame: 6 MONTHS). 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 NCT01220011, which also lists 1 linked publication.
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 13 Feb 2026.