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Pregnant With ComplicationNCT04148859

Feto-Fetal Transfusion Syndrome in Multiple Pregnancies

A study testing amnioreduction in people with Pregnant With Complication, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objectives: Twin-to-twin transfusion syndrome (TTTS) generates high risk for one of the twins, may lead to preterm delivery and is also associated with neurodevelopmental deficits. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Pregnant With Complication
What is being tested?
amnioreduction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteIsrael
Study dates
Nov 2004to Nov 2025
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Pregnancies with TTTS

Who cannot join

  • Pregnancies with malformations or genetic pathologies

Trial locations and contacts

1 site in 1 country.

Israel1 site, 1 recruiting
  • Zoya Gordon

    Tel Aviv, 64239

    Zoya Gordon, PhD, 972-3-692-5759, zoyag@tasmc.health.gov.il

    Recruiting

Other trials in Israel

About this study

Objectives: Twin-to-twin transfusion syndrome (TTTS) generates high risk for one of the twins, may lead to preterm delivery and is also associated with neurodevelopmental deficits. The aim of this study was to explore a controlled amnioreduction (AR) procedure in which the amniotic pressure is simultaneously measured with the removed volume of amniotic pressure.

Methods: Eleven patients with severe TTTS at stages II and III of Quintero classification were enrolled to the study. The amniotic pressure was measured along with the removed volume of the amniotic pressure between 17-34 weeks of gestation. The umbilical artery S/D ratio for each twin was measured at the beginning and after every 500cc of removed amniotic fluid. Long-term neurodevelopmental outcome of infants with TTTS was evaluated from a questionnaire for assessing the overall health of the surviving twins.

Read the detailed description

The placentation of monozygotic twins depends on the stage at which duplication occurs. A monochorionic diamniotic placenta type occurs when the blastocyst splits between days 3 8 after fertilization when the trophoblast but not the amniotic cavity has differentiated. The blood vessels of the twins of such a placenta form superficial or deep anastomoses (Denbow et al., 2000). The anastomoses may communicate between an artery of one twin to an artery of the other one (A-A), vein to vein (V-V) or artery to vein (A-V). The superficial anastomoses are the ones between fairly large vessels on the chorionic plate, where the majority of them are A A. These anastomoses are bidirectional, and allow rapid flow between the twins, depending on pressure gradient. The A-V anastomoses are usually deep and occur in a shared cotyledon where the connection is via the capillary system. These anastomoses are unidirectional and result in an asymmetric flow from one twin to another (Fox, 1997; Bajoria, 1998; Taylor et al, 1999; De Paepe et al, 2002).

Monochorionic diamniotic placentas may be diagnosed by ultrasonography (US) at 8 10 weeks of gestation in the presence of a single placenta, similar genitalia, an intrafetal septum <2 mm thick, and the absence of a twin peak sign (Bajoria, 1998). Twin-twin transfusion syndrome (TTTS) is a major complication of a monochorionic placenta which occurs in 10% 15% of monochorionic multiple pregnancies (Sebire et al, 1997) due to blood transfusion from one twin (the donor) to the other (the recipient) (Bajoria et al, 1995; Talbert et al, 1996). The donor twin becomes anemic and the amount of its amniotic fluid decreases, while the recipient becomes polycythemic, causing polyhydramnios. The cause for the development of TTTS accounts for the types of anastomoses. Mild TTTS has a single deep A V anastomosis along with superficial A-A and V-V anastomoses, whereas severe TTTS lacks the superficial anastomoses (Bajoria, 1998; Denbow et al, 1998; Bermudez et al, 2002). It was postulated that a single, deep A-V anastomosis causes asymmetric blood flow from one twin to the other (3)(Bajoria, 1998). The effect of an asymmetric blood flow is minimized when superficial anastomoses are present together with an A-V anastomosis (Denbow et al, 2000). Superficial anastomoses are clearly observed on the chorionic plate. Deep anastomoses, i.e., the A-V type, represent a shared cotyledon in which the arterial supply is derived from one twin and the venous drainage is to the other (Denbow et al., 1998). Thus, A-V anastomoses may be suspected by an unpaired artery of one twin and an unpaired vein of the other twin being dipped closely into the placenta at a distance <1 cm (De Paepe et al., 2002).

Monochorionic twins have an approximately 25% rate of perinatal morbidity and mortality, which is much higher than singleton and dichorionic twins (Kaufman et al, 1998; De Catte et al., 2002; Chow et al., 2001). No single therapy is associated with a uniformly improved outcome for the involved twins and success is primarily related to gestational age and severity at diagnosis. Treatment options for severe cases include serial amniocenteses, septostomy, laser occlusion of placental vessels, digitalization, ligation of the umbilical cord and selective feticide. These modalities are associated with significant risks of complications, and variable results of fetal morbidity and mortality. Therefore, they should be considered when risks of withholding treatment clearly outweigh those associated with intervention (Ropacka et al, 2002).

The serial amnioreduction is currently the most widely used therapy because it is simple and requires commonly available skilled and equipment. The excess amniotic fluid volume which can vary from 0.5 to few liters are removed, reducing the excess amniotic fluid and pressure, and potentially preventing or delaying rupture of the membranes or preterm labor. Amnioreduction carries a related risk of delivery of 4% per procedure (Van Gemert et al, 2001).

Obliteration of placental anastomoses is the obvious causal therapy of TTTS, because placental anastomoses cause oligo-polyhydramnios sequence of TTTS. The fetoscopic laser coagulates placental vascular anastomoses along the inter-twin septum. However, few anastomoses may be located at the donor side or hidden by the stuck twin and thus, coagulation is limited. TTTS can worsen if compensating vessels (bidirectional) are coagulated instead of significant AV. The risk of procedure-related spontaneous abortion is greater after laser therapy than single amnioreduction. The advantage of amnioreduction changes after three procedures (Van Gemert et al, 2001).

TTTS is not completely understood and is controversial which hampers development of acceptable diagnostic and rational treatment strategies. In this research we would like to investigate the mechanism which improves both twins blood flow after amnioreduction. Such knowledge may improve future management of TTTS. We will recruit 11 women who have to undergo amnioreduction due to TTTS. The amniotic fluid is drained via needle, which is stubbed in the abdomen wall, connected to a tube into a plastic bag. The amniotic fluid pressure will be measured by a water manometer. AT-shape connector will be connected to the tube on one side, and to a short tube on the other side. The height of the fluid within the short tube will indicate the pressure. All the fluid will be drained to the plastic bag. The pressure and the blood flow of the fetuses will be measured during the procedure, depends on the drainage rate. We will include cases of multiple pregnancies with TTTS who must undergo amnioreduction. Pregnancies with malformations or genetic pathologies will be excluded. In addition, we also will explore the long-term neurodevelopmental outcome of children born following a pregnancy complicated by TTTS whose mothers underwent the controlled AR.

Being tested
amnioreduction
Keywords
TTTS, controlled amnioreduction, amniotic pressure
Medical subject headings
Pregnancy Complications

What participants receive

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

  • amnioreductionProcedure or surgery

    The amniotic fluid is drained via needle, which is stubbed in the abdomen wall, connected to a tube into a plastic bag. The amniotic fluid pressure will be measured by a water manometer. A T-shape connector will be connected to the tube on one side, and to a short tube on the other side. The height of the fluid within the short tube will indicate the pressure. All the fluid will be drained to the plastic bag. The pressure and the blood flow of the fetuses will be measured during the procedure, depends on the drainage rate.

Study groups in NCT04148859
Study groupRoleWhat they receive
pregnant womenExperimentalwomen who have to undergo amnioreduction due to TTTS
Receives: Procedure: amnioreduction

What is being measured

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

  1. The amniotic pressure

    The amniotic fluid pressure will be measured at the beginning and after every 500cc of removed amniotic fluid by a water manometer. The pattern of the decreasing amniotic pressure during removal of the excess volume of fluid will be depicted.

    Measured: The duration of measurements will be about 80 minutes per procedure.

Secondary outcomes (2)
  1. The removed amniotic volume

    The removed volume of fluid will be recorded every 500 ml using a sterile bag.

    Measured: The duration of measurements will be about 80 minutes per procedure.

  2. The umbilical artery S/D ratio

    The umbilical artery S/D ratio for each twin will be measured with a Doppler ultrasound machine at the beginning and after every 500cc of removed amniotic fluid. The graph of the umbilical artery S/D ratio vesus weeks of gestation will be plotted.

    Measured: The duration of measurements will be about 80 minutes per procedure.

Timeline

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

  1. First posted4 Nov 2019
  2. Study startNov 2004
  3. Primary completionNov 2025 (estimated)
  4. Study completionNov 2025 (estimated)

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
Model description
We will recruit 11 women who have to undergo amnioreduction due to TTTS. The amniotic fluid is drained via needle, which is stubbed in the abdomen wall, connected to a tube into a plastic bag. The amniotic fluid pressure will be measured by a water manometer. A T-shape connector will be connected to the tube on one side, and to a short tube on the other side. The height of the fluid within the short tube will indicate the pressure. All the fluid will be drained to the plastic bag. The pressure and the blood flow of the fetuses will be measured during the procedure, depends on the drainage rate. We will include cases of multiple pregnancies with TTTS who must undergo amnioreduction.
Masking
None (open label)
Enrolment
11 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04148859
Sponsor's protocol ID
04-220
Status last verified
Oct 2019
First submitted
20 Oct 2019
Last updated
4 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No

Questions about this trial

What is this clinical trial studying?

A study testing amnioreduction in people with Pregnant With Complication, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

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: status not confirmed, as of the sponsor's last update on 4 Nov 2019. 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 Israel. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zoya Gordon, PhD (972-3-692-5759, zoyag@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The amniotic pressure (time frame: The duration of measurements will be about 80 minutes per procedure.). 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 4 Nov 2019.

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