Twin Anemia Polycythemia SequenceNCT04432168
The TAPS Trial - Fetoscopic Laser Surgery for Twin Anemia Polycythemia Sequence
A study testing Fetoscopic Laser Surgery and Standard Treatment in people with Twin Anemia Polycythemia Sequence, run by Leiden University Medical Center at 5 sites in 5 countries.
Trial summary
This multicenter open-label randomized controlled trial is set up to evaluate the effect of fetoscopic laser surgery on the gestational age at birth for monochorionic twin pregnancies diagnosed with twin anemia-polycythemia sequence. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Twin Anemia Polycythemia Sequence
- What is being tested?
- Fetoscopic Laser Surgery and Standard Treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 30 Apr 2019to 30 Apr 2024
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Monochorionic twin pregnancy complicated by either spontaneous or post-laser twin anemia polycythemia sequence (TAPS), stage ≥ 2, diagnosed between 20+0 and till 28+0 weeks of gestation
- Women aged 18 years or more, who are able to consent.
- Written informed consent to participate in this randomized controlled trial, forms being approved by the Ethical Committees.
Who cannot join
- TAPS stage 1
- TAPS stage≥ 2, diagnosed within 1 week after laser surgery for twin-twin transfusion syndrome (TTTS) (a large inter-twin middle cerebral artery peak systolic velocity difference within a week after laser for TTTS is likely to related to hemodynamic reequilibration, and is usually not based on TAPS)
- Triplet pregnancies, or higher order multiple pregnancies
- TAPS cases that already underwent an intrauterine treatment (with the exception of laser surgery for TTTS in post-laser TAPS cases)
- Congenital abnormalities (including severe cerebral injury) in one or both twins
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site, 1 recruiting
- Not yet recruiting
Yale University
New Haven, Connecticut, 208327
Ozan Bahtiyar, MD PhD
Ozan Bahtiyar, MD PhD
Italy1 site, 1 recruiting
- Recruiting
Vittore Buzzi Children's Hospital
Milan, Lombardy, 20154
Mariano Lanna, MD PhD, info@terapiafetale.it
Mariano Lanna, MD PhD
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333ZA
Dick Oepkes, MD PhD, +31715261688, d.oepkes@lumc.nl
Femke Slaghekke, MD PhD, +31715297211, f.slaghekke@lumc.nl
Spain1 site, 1 recruiting
- Recruiting
Vall d'Hebron University Hospital
Barcelona, 08035
Carlota Rodo, MD PhD, crodo@vhebron.net
Silivia Arevalo, MD PhD, siareval@vhebron.net
Sweden1 site, 1 recruiting
- Not yet recruiting
Karolinska University Hospital
Stockholm, Södermanland County, 141 86
Lotta Herling, MD PhD, lotta.herling@sll.se
Lotta Herling, MD PhD
About this study
Official title: The TAPS Trial - Fetoscopic Laser Surgery for Twin Anemia-Polycythemia Sequence - a Multicenter Open-Label Randomized Controlled Trial
This multicenter open-label randomized controlled trial is set up to evaluate the effect of fetoscopic laser surgery on the gestational age at birth for monochorionic twin pregnancies diagnosed with twin anemia-polycythemia sequence. Half op the patients will be treated with fetoscopic laser surgery, while the other half will be managed with standard treatment. The hypothesis is that fetoscopic laser therapy will improve neonatal outcome by prolonging pregnancy.
Read the detailed description
Rationale: Monochorionic twins share one placenta and are connected to each other via vascular anastomoses at the placental surface, allowing the blood to transfer bi-directionally between the two fetuses. Unbalanced inter-twin blood transfusion can result in twin anemia-polycythemia sequence (TAPS). Management options include: fetoscopic laser surgery, intrauterine blood transfusion (IUT) with or without partial exchange transfusion (PET), preterm delivery, selective feticide and expectant management. The optimal treatment for TAPS is not clear. Fetoscopic laser surgery is the only causative treatment option, but data on the feasibility of this procedure are mainly based on case reports and small cohort studies. A large randomized controlled trial is needed to evaluate the possible beneficial effect of fetoscopic laser surgery and to determine the optimal treatment option for TAPS.
Objective: The aim of this trial is to investigate whether fetoscopic laser surgery improves the outcome for TAPS twins as compared to the control group (standard care consisting of expectant management, IUT, preterm delivery). The hypothesis is that fetoscopic laser therapy will improve neonatal outcome by prolonging pregnancy.
Study design: International multi-centered open-label randomized controlled trial to assess whether fetoscopic laser surgery (experimental group) improves the outcome of TAPS twins compared to standard care (control group).
Study population: Monochorionic twin pregnancies with TAPS stage ≥ 2 (spontaneous or post-laser) diagnosed between 20 and 28 weeks of gestation.
Intervention: In the experimental group fetoscopic laser surgery is performed, whereas the control group is treated with standard care (expectant management, IUT (with PET), selective feticide and/or preterm delivery, depending on the opinion of the fetal surgeon).
Main study endpoints: The primary outcome is gestational age at birth. Secondary outcomes include: perinatal mortality or severe neonatal morbidity, hematological complication, procedure related complications and long-term neurodevelopmental outcome at 2 years.
- Conditions
- Twin Anemia Polycythemia Sequence
- Being tested
- Fetoscopic Laser Surgery, Standard Treatment
- Keywords
- Monochorionic Twins, Twin-Twin Transfusion Syndrome, Fetoscopic Laser Surgery, Intrauterine Transfusion, Partial Exchange Transfusion
- Medical subject headings
- 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
Also called Fetoscopic Laser Coagulation, Laser therapy, Fetoscopic Laser Ablation
Fetoscopic Photocoagulation of the connecting vascular anastomoses on the surface of the placenta.
Standard TreatmentOther
In the control group, the choices of treatment include expectant management, intrauterine transfusion (IUT) (with or without partial exchange transfusion (PET)) or preterm delivery, depending on the judgment of the fetal surgeon with regard to the gestational age and state of the disease.
- Expectant management will consist of close monitoring with ultrasound including Doppler measurements of the middle cerebral artery peak systolic velocity (MCA-PSV), at least every week.
- IUT: the intrauterine infusion of red blood cells into the circulation of the donor twin treat anemia.
- PET: the intrauterine infusion of saline into the circulation of the recipient twin to treat polycythemia.
- Preterm delivery: Induction of labor or cesarean section before 36 weeks of gestation.
| Study group | Role | What they receive |
|---|---|---|
| Fetoscopic Laser Surgery | Experimental | fetoscopic laser coagulation of the vascular anastomoses at the placental surface Receives: Procedure: Fetoscopic Laser Surgery |
| Standard Treatment | Other | Expectant management, IUT (with or without PET), preterm delivery Receives: Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational Age at Birth
Gestational age: completed weeks + additional days since the first day of the last menstruational period of the mother.
Measured: 2 weeks after expected date of birth
Secondary outcomes (7)
Number of patients with perinatal mortality
Perinatal mortality is defined as fetal death or neonatal death (demise of a liveborn child within 28 days after birth)
Measured: 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth
Number of patients with severe neonatal morbidity
Severe neonatal morbidity is defined as the presence of at least one of the following:
- Respiratory distress syndrome requiring surfactant or mechanical ventilation
- Proven early onset neonatal sepsis with positive blood cultures within 72 hours postpartum
- Retinopathy of prematurity stage 3 or higher
- Necrotizing enterocolitis stage 2 or higher
- Patent ductus arteriosus requiring medical therapy or surgical closure
- Severe cerebral injury (defined as intraventricular hemorrhage grade 3 or higher, cystic periventricular leukomalacia grade 2 or higher, ventricular dilatation greater than the 97th centile, porencephalic or parenchymal cysts or other severe cerebral lesions)
Measured: 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth
Number of patients with hematological complications
Hematological complications are defined as the presence of at least one of the following:
- Anemia in donor requiring a blood transfusion within 24 hours after birth
- Polycythemia in recipient requiring a partial exchange transfusion within 24 hours after birth
- necrotic skin injury
- limb ischemia
- platelet count < 150,000/microL
- albumin levels < 20 g/L
- protein levels < 40 g/L
Measured: 2 weeks after expected date of birth
Number of patients with procedure-related complications
Procedure-related complications are defined as at least one of the following:
- amniotic band syndrome
- iatrogenic monoamnionicity
- Preterm premature rupture of the membranes
- Placental abruption
- clinical chorioamnionitis
- histological chorioamnionitis and/or funisitis
Measured: 2 weeks after expected date of birth
Number of patient with mild neurodevelopmental impairment
Mild neurodevelopmental impairment is defined as at least one of the following:
- cerebral palsy (spastic bilateral, spastic unilateral, or mixed)
- Impaired cognitive or motor development defined as Score < 85 (1 standard deviation (SD) below the mean) as assessed by Bayley Scales of Infant and Toddler Development version 3 (BSID-III)
- Impaired functioning in communication, fine and gross motor, problem solving, personal and social functioning defined as Score > 1 SD below the mean as assessed by Ages and Stages Questionnaire version 3 (ASQ-III)
- severe visual loss (blind or partially sighted)
- severe hearing loss (needing hearing aids)
Measured: 2 years after expected date of birth
Number of patients with severe neurodevelopmental impairment
Severe neurodevelopmental impairment is defined as at least one of the following:
- cerebral palsy defined as a gross motor function classification system (CMFCS) grade > 1
- Impaired cognitive or motor development defined as a score < 70 (2 SD below the mean) as assessed by the Bayley Scales of Infant and Toddler Development version 3 (BSID-III)
- Impaired functioning in communication, fine and gross motor, problem solving, personal and social functioning defined as a score > 2 SD below the mean as assessed by Ages and Stages Questionnaire version 3 (ASQ-III)
- Bilateral blindness defined as visual acuity of less than 3/60 in the better eye
- Bilateral deafness defined as severe or profound hearing loss in both ears (severe hearing loss: a person can only hear sounds > 70-89 decibel , profound hearing loss: a person can only hear sounds > 90 decibel
Measured: 2 years after expected date of birth
Number of patients with behavioral problems
Behavioral problems are defined as a T-score ≥ 64 for one of the following broad band scales: total problem score, Internalizing problems (anxious/depressed, withdrawn, somatic complaints), Externalizing problems (rule-breaking, aggressive behavior) as measured with the Child Behaviour Checklist 1.5-5 years
Measured: 2 years after expected date of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start30 Apr 2019
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Twin Anemia Polycythemia SequenceStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DickOepkes, Leiden University Medical Center
- Investigators
- Dick Oepkes, MD PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432168
- Sponsor's protocol ID
- NL6442700018
- Status last verified
- Jun 2020
- First submitted
- 11 May 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopriore E, Middeldorp JM, Oepkes D, Kanhai HH, Walther FJ, Vandenbussche FP. Twin anemia-polycythemia sequence in two monochorionic twin pairs without oligo-polyhydramnios sequence. Placenta. 2007 Jan;28(1):47-51. doi: 10.1016/j.placenta.2006.01.010. Epub 2006 Mar 3.
PubMed 16516289Robyr R, Lewi L, Salomon LJ, Yamamoto M, Bernard JP, Deprest J, Ville Y. Prevalence and management of late fetal complications following successful selective laser coagulation of chorionic plate anastomoses in twin-to-twin transfusion syndrome. Am J Obstet Gynecol. 2006 Mar;194(3):796-803. doi: 10.1016/j.ajog.2005.08.069.
PubMed 16522415Sananes N, Veujoz M, Severac F, Barthoulot M, Meyer N, Weingertner AS, Kohler M, Guerra F, Gaudineau A, Nisand I, Favre R. Evaluation of the Utility of in utero Treatment of Twin Anemia-Polycythemia Sequence. Fetal Diagn Ther. 2015;38(3):170-8. doi: 10.1159/000380822. Epub 2015 Mar 17.
PubMed 25790745Slaghekke F, Favre R, Peeters SH, Middeldorp JM, Weingertner AS, van Zwet EW, Klumper FJ, Oepkes D, Lopriore E. Laser surgery as a management option for twin anemia-polycythemia sequence. Ultrasound Obstet Gynecol. 2014 Sep;44(3):304-10. doi: 10.1002/uog.13382. Epub 2014 Aug 4.
PubMed 24706478
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TAPS Trial - Fetoscopic Laser Surgery for Twin Anemia-Polycythemia Sequence - a Multicenter Open-Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04432168
- Acronym / sponsor ID
- NL6442700018
- Conditions
- Twin Anemia Polycythemia Sequence
- Keywords
- Monochorionic Twins, Twin-Twin Transfusion Syndrome, Fetoscopic Laser Surgery, Intrauterine Transfusion, Partial Exchange Transfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 16 Jun 2020 (actual)
- 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.
This multicenter open-label randomized controlled trial is set up to evaluate the effect of fetoscopic laser surgery on the gestational age at birth for monochorionic twin pregnancies diagnosed with twin anemia-polycythemia sequence. Half op the patients will be treated with fetoscopic laser surgery, while the other half will be managed with standard treatment. The hypothesis is that fetoscopic laser therapy will improve neonatal outcome by prolonging pregnancy.
Detailed description
Rationale: Monochorionic twins share one placenta and are connected to each other via vascular anastomoses at the placental surface, allowing the blood to transfer bi-directionally between the two fetuses. Unbalanced inter-twin blood transfusion can result in twin anemia-polycythemia sequence (TAPS). Management options include: fetoscopic laser surgery, intrauterine blood transfusion (IUT) with or without partial exchange transfusion (PET), preterm delivery, selective feticide and expectant management. The optimal treatment for TAPS is not clear. Fetoscopic laser surgery is the only causative treatment option, but data on the feasibility of this procedure are mainly based on case reports and small cohort studies. A large randomized controlled trial is needed to evaluate the possible beneficial effect of fetoscopic laser surgery and to determine the optimal treatment option for TAPS.
Objective: The aim of this trial is to investigate whether fetoscopic laser surgery improves the outcome for TAPS twins as compared to the control group (standard care consisting of expectant management, IUT, preterm delivery). The hypothesis is that fetoscopic laser therapy will improve neonatal outcome by prolonging pregnancy.
Study design: International multi-centered open-label randomized controlled trial to assess whether fetoscopic laser surgery (experimental group) improves the outcome of TAPS twins compared to standard care (control group).
Study population: Monochorionic twin pregnancies with TAPS stage ≥ 2 (spontaneous or post-laser) diagnosed between 20 and 28 weeks of gestation.
Intervention: In the experimental group fetoscopic laser surgery is performed, whereas the control group is treated with standard care (expectant management, IUT (with PET), selective feticide and/or preterm delivery, depending on the opinion of the fetal surgeon).
Main study endpoints: The primary outcome is gestational age at birth. Secondary outcomes include: perinatal mortality or severe neonatal morbidity, hematological complication, procedure related complications and long-term neurodevelopmental outcome at 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fetoscopic Laser Surgery | Experimental | Procedure: Fetoscopic Laser Surgeryfetoscopic laser coagulation of the vascular anastomoses at the placental surface |
| Standard Treatment | Other | Other: Standard TreatmentExpectant management, IUT (with or without PET), preterm delivery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Monochorionic twin pregnancy complicated by either spontaneous or post-laser twin anemia polycythemia sequence (TAPS), stage ≥ 2, diagnosed between 20+0 and till 28+0 weeks of gestation
- Women aged 18 years or more, who are able to consent.
- Written informed consent to participate in this randomized controlled trial, forms being approved by the Ethical Committees.
Key exclusion criteria (5 listed)
- TAPS stage 1
- TAPS stage≥ 2, diagnosed within 1 week after laser surgery for twin-twin transfusion syndrome (TTTS) (a large inter-twin middle cerebral artery peak systolic velocity difference within a week after laser for TTTS is likely to related to hemodynamic reequilibration, and is usually not based on TAPS)
- Triplet pregnancies, or higher order multiple pregnancies
- TAPS cases that already underwent an intrauterine treatment (with the exception of laser surgery for TTTS in post-laser TAPS cases)
- Congenital abnormalities (including severe cerebral injury) in one or both twins
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 SurgeryAlso: Fetoscopic Laser Coagulation, Laser therapy, Fetoscopic Laser AblationFetoscopic Photocoagulation of the connecting vascular anastomoses on the surface of the placenta. | Procedure or surgery | Fetoscopic Laser Surgery |
| Standard TreatmentIn the control group, the choices of treatment include expectant management, intrauterine transfusion (IUT) (with or without partial exchange transfusion (PET)) or preterm delivery, depending on the judgment of the fetal surgeon with regard to the gestational age and state of the disease. * Expectant management will consist of close monitoring with ultrasound including Doppler measurements of the middle cerebral artery peak systolic velocity (MCA-PSV), at least every week. * IUT: the intrauterine infusion of red blood cells into the circulation of the donor twin treat anemia. * PET: the intrauterine infusion of saline into the circulation of the recipient twin to treat polycythemia. * Preterm delivery: Induction of labor or cesarean section before 36 weeks of gestation. | Other | Standard Treatment |
Primary outcome
Gestational Age at Birth
Time frame: 2 weeks after expected date of birth
Gestational age: completed weeks + additional days since the first day of the last menstruational period of the mother.
7 secondary outcomes
Number of patients with perinatal mortality
Time frame: 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth
Number of patients with severe neonatal morbidity
Time frame: 42 days (28 days neonatal period+2 weeks postdates) after expected date of birth
Number of patients with hematological complications
Time frame: 2 weeks after expected date of birth
Number of patients with procedure-related complications
Time frame: 2 weeks after expected date of birth
Number of patient with mild neurodevelopmental impairment
Time frame: 2 years after expected date of birth
Number of patients with severe neurodevelopmental impairment
Time frame: 2 years after expected date of birth
Number of patients with behavioral problems
Time frame: 2 years after expected date of birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 16516289Lopriore E, Middeldorp JM, Oepkes D, Kanhai HH, Walther FJ, Vandenbussche FP. Twin anemia-polycythemia sequence in two monochorionic twin pairs without oligo-polyhydramnios sequence. Placenta. 2007 Jan;28(1):47-51. doi: 10.1016/j.placenta.2006.01.010. Epub 2006 Mar 3.
- Background: PubMed 16522415Robyr R, Lewi L, Salomon LJ, Yamamoto M, Bernard JP, Deprest J, Ville Y. Prevalence and management of late fetal complications following successful selective laser coagulation of chorionic plate anastomoses in twin-to-twin transfusion syndrome. Am J Obstet Gynecol. 2006 Mar;194(3):796-803. doi: 10.1016/j.ajog.2005.08.069.
- Background: PubMed 25790745Sananes N, Veujoz M, Severac F, Barthoulot M, Meyer N, Weingertner AS, Kohler M, Guerra F, Gaudineau A, Nisand I, Favre R. Evaluation of the Utility of in utero Treatment of Twin Anemia-Polycythemia Sequence. Fetal Diagn Ther. 2015;38(3):170-8. doi: 10.1159/000380822. Epub 2015 Mar 17.
- Background: PubMed 24706478Slaghekke F, Favre R, Peeters SH, Middeldorp JM, Weingertner AS, van Zwet EW, Klumper FJ, Oepkes D, Lopriore E. Laser surgery as a management option for twin anemia-polycythemia sequence. Ultrasound Obstet Gynecol. 2014 Sep;44(3):304-10. doi: 10.1002/uog.13382. Epub 2014 Aug 4.
- Individual participant dataSharing planned: No
Related trials for Twin Anemia Polycythemia Sequence
Recruiting
Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
Twin to Twin Transfusion Syndrome, Twin Anemia-Polycythemia Sequence
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.
Dick Oepkes, MD PhD principal investigator
Leiden University Medical Center
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetoscopic Laser Surgery and Standard Treatment in people with Twin Anemia Polycythemia Sequence, run by Leiden University Medical Center at 5 sites in 5 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 3 inclusion and 5 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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Italy, Netherlands, Spain, Sweden. 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 Femke Slaghekke, MD PhD (+31 71 52 97211, f.slaghekke@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational Age at Birth (time frame: 2 weeks after expected date of birth). 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 NCT04432168, which also lists 4 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 16 Jun 2020.