Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome

Brief Title

Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome

Official Title

STT Study : Pediatric Follow-up of Children's From Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome

Brief 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. 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 Type

Observational


Primary Outcome

Composite measure of the cardiac function

Secondary Outcome

 Composite measure of the glycoregulation

Condition

Twin to Twin Transfusion Syndrome


Study Arms / Comparison Groups

 monochorial-biamniotic pregnancies
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

179

Start Date

April 3, 2007

Completion Date

December 31, 2022

Primary Completion Date

June 30, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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
      

Gender

All

Ages

4 Years - 8 Years

Accepts Healthy Volunteers

No

Contacts

Laurence Bussières, Ph.D, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02611856

Organization ID

CRC05069


Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

 Société Française d'Hypentension Artérielle

Study Sponsor

Laurence Bussières, Ph.D, Principal Investigator, Assistance Publique - Hôpitaux de Paris


Verification Date

August 2018