Twin to Twin Transfusion SyndromeSTTNCT02611856
Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome
An observational study of Twin to Twin Transfusion Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The twin pregnancies monochorionic are specifically explained to two main types of complications: the anomalies of the embryo affecting a symmetry and in particular the median line on one hand and malformative sequences of vascular origin on the other hand. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Twin to Twin Transfusion Syndrome
- How many people
- 179 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2007to 31 Dec 2022
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 4 years to 8 years
Who may be able to join
- Child (ren) from (s) of a twin pregnancy with fetal transfusion syndrome fetal
- Child (ren) age (s) 4 years 0 months to 6 years 12 months
- Child (ren) fasting
- Consent signed by the parents or legal representative
Who cannot join
- Child (ren) not derived (s) of a twin pregnancy with fetal transfusion syndrome fetal
- Child (ren) age (s) under 4 years 0 months or more than 6 years 12 months
- Child (ren) nonfasting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STT Study : Pediatric Follow-up of Children's From Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome
The twin pregnancies monochorionic are specifically explained to two main types of complications: the anomalies of the embryo affecting a symmetry and in particular the median line on one hand and malformative sequences of vascular origin on the other hand. This last category of anomalies (twin-to-twin syndrome, TTTS) develops because of the presence of a division of the foeto-placentary circulation between both twins through the pooling of certain placentary cotyledons. The latter are then vascularized by an arterial and venous foot belonging to both foetuses (anastomoses arteria-venous or veinous-arterial). It results from it an imbalance moderate but very early hemodynamic which is going to return a hypovolume twin (the donor) and its plethoric co-twin (the recipient).
These anomalies in utero could not only have consequences during the fetal life, on the born weight and the later development of newborns, but also on the organization and the functioning of a whole series of physiological systems. So these anomalies of the pregnancy could have also consequences which exceed by very far from the perinatal period, by favoring the development of the atheroma, the high blood pressure, the resistance in the insulin, and many other metabolic and endocrine functions were known for their importance in human pathology.
Read more
For these reasons the investigators suggest estimating the tensional, cardiac and metabolic status of children ex-transfusers and of children ex-transfused in 2 different age classes: between 4 and 8 years then when these children will have between 12 and 16 years.
There are also some evaluation clinical and biological of the puberty (only at the age of 12-16)
To understand a possible effect of the prenatal status of these children on the endocrinology of the puberty, the measures and the following dosages will be realized:
- Test in the GnRH (T0, T30, T60, T90): dosages of LH and FSH (relationship of peaks to determine the puberty evolution),
- Dosages of the sexual steroids, the oestradiol for the girl and the testosterone for the boy,
- Clinical examination looking for the signs of puberty
This if study leans on the big originality of the physiopathological model of TTTS in which the children present the peculiarity to have an identical genetic and postnatal status and a different prenatal environment.
The follow-up of these children should allow:
- To understand better the postnatal impact anomalies on these children in the course of pregnancy
- To anticipate and thus to improve their care in case of appearance of biological or clinical signs
- Conditions
- Twin to Twin Transfusion Syndrome
- Keywords
- twin to twin,, transfusion syndrome
- Medical subject headings
- Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| monochorial-biamniotic pregnancies | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of the cardiac function
- measure of the arterial blood pressure
- cardiac echography
Measured: one day
Composite measure of the renal function
- microalbuminuria
- level of plasmatic renin, plasmatic cortisol, prorenin, aldosterone
- renal echography
Measured: one day
Secondary outcomes (1)
Composite measure of the glycoregulation
- provoked oral hyperglycemia
- level of glycemia
- level of insulinemia
- level of glycosuria
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study start3 Apr 2007
- Primary completion30 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Twin to Twin Transfusion SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Société Française d'Hypentension Artérielle, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Yves Ville, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611856
- Sponsor's protocol ID
- P050314
- Other IDs
- CRC05069
- Acronym
- STT
- Status last verified
- Mar 2026
- First submitted
- 2 Jul 2015
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Stirnemann J, Djaafri F, Kim A, Mediouni I, Bussieres L, Spaggiari E, Veluppillai C, Lapillonne A, Kermorvant E, Magny JF, Colmant C, Ville Y. Preterm premature rupture of membranes is a collateral effect of improvement in perinatal outcomes following fetoscopic coagulation of chorionic vessels for twin-twin transfusion syndrome: a retrospective observational study of 1092 cases. BJOG. 2018 Aug;125(9):1154-1162. doi: 10.1111/1471-0528.15147. Epub 2018 Mar 1.
PubMed 29380497Le Lous M, Mediouni I, Chalouhi G, Salomon LJ, Bussieres L, Carrier A, Bernard JP, Ville Y. Impact of laser therapy for twin-to-twin transfusion syndrome on subsequent pregnancy. Prenat Diagn. 2018 Mar;38(4):293-297. doi: 10.1002/pd.5227. Epub 2018 Feb 19.
PubMed 29417606
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STT Study : Pediatric Follow-up of Children's From Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome
- ClinicalTrials.gov ID
- NCT02611856
- Acronym / sponsor ID
- STT / P050314
- Conditions
- Twin to Twin Transfusion Syndrome
- Keywords
- twin to twin,, transfusion syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Société Française d'Hypentension Artérielle, URC-CIC Paris Descartes Necker Cochin
- Study start
- 3 Apr 2007 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Nov 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.
The twin pregnancies monochorionic are specifically explained to two main types of complications: the anomalies of the embryo affecting a symmetry and in particular the median line on one hand and malformative sequences of vascular origin on the other hand. This last category of anomalies (twin-to-twin syndrome, TTTS) develops because of the presence of a division of the foeto-placentary circulation between both twins through the pooling of certain placentary cotyledons. The latter are then vascularized by an arterial and venous foot belonging to both foetuses (anastomoses arteria-venous or veinous-arterial). It results from it an imbalance moderate but very early hemodynamic which is going to return a hypovolume twin (the donor) and its plethoric co-twin (the recipient).
These anomalies in utero could not only have consequences during the fetal life, on the born weight and the later development of newborns, but also on the organization and the functioning of a whole series of physiological systems. So these anomalies of the pregnancy could have also consequences which exceed by very far from the perinatal period, by favoring the development of the atheroma, the high blood pressure, the resistance in the insulin, and many other metabolic and endocrine functions were known for their importance in human pathology.
For these reasons the investigators suggest estimating the tensional, cardiac and metabolic status of children ex-transfusers and of children ex-transfused in 2 different age classes: between 4 and 8 years then when these children will have between 12 and 16 years.
There are also some evaluation clinical and biological of the puberty (only at the age of 12-16)
To understand a possible effect of the prenatal status of these children on the endocrinology of the puberty, the measures and the following dosages will be realized:
- Test in the GnRH (T0, T30, T60, T90): dosages of LH and FSH (relationship of peaks to determine the puberty evolution),
- Dosages of the sexual steroids, the oestradiol for the girl and the testosterone for the boy,
- Clinical examination looking for the signs of puberty
This if study leans on the big originality of the physiopathological model of TTTS in which the children present the peculiarity to have an identical genetic and postnatal status and a different prenatal environment.
The follow-up of these children should allow:
- To understand better the postnatal impact anomalies on these children in the course of pregnancy
- To anticipate and thus to improve their care in case of appearance of biological or clinical signs
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| monochorial-biamniotic pregnancies | – | – |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 4 years to 8 years
Key inclusion criteria (4 listed)
- Child (ren) from (s) of a twin pregnancy with fetal transfusion syndrome fetal
- Child (ren) age (s) 4 years 0 months to 6 years 12 months
- Child (ren) fasting
- Consent signed by the parents or legal representative
Key exclusion criteria (3 listed)
- Child (ren) not derived (s) of a twin pregnancy with fetal transfusion syndrome fetal
- Child (ren) age (s) under 4 years 0 months or more than 6 years 12 months
- Child (ren) nonfasting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite measure of the cardiac function
Time frame: one day
* measure of the arterial blood pressure * cardiac echography
Composite measure of the renal function
Time frame: one day
* microalbuminuria * level of plasmatic renin, plasmatic cortisol, prorenin, aldosterone * renal echography
1 secondary outcome
Composite measure of the glycoregulation
Time frame: one day
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 27 Mar 2026.
- Results publication: PubMed 29380497Stirnemann J, Djaafri F, Kim A, Mediouni I, Bussieres L, Spaggiari E, Veluppillai C, Lapillonne A, Kermorvant E, Magny JF, Colmant C, Ville Y. Preterm premature rupture of membranes is a collateral effect of improvement in perinatal outcomes following fetoscopic coagulation of chorionic vessels for twin-twin transfusion syndrome: a retrospective observational study of 1092 cases. BJOG. 2018 Aug;125(9):1154-1162. doi: 10.1111/1471-0528.15147. Epub 2018 Mar 1.
- Results publication: PubMed 29417606Le Lous M, Mediouni I, Chalouhi G, Salomon LJ, Bussieres L, Carrier A, Bernard JP, Ville Y. Impact of laser therapy for twin-to-twin transfusion syndrome on subsequent pregnancy. Prenat Diagn. 2018 Mar;38(4):293-297. doi: 10.1002/pd.5227. Epub 2018 Feb 19.
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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, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Twin to Twin Transfusion Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 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 27 Mar 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 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?
Composite measure of the cardiac function (time frame: one day). 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?
On the ClinicalTrials.gov record for NCT02611856, which also lists 2 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 27 Mar 2026.