- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01978561
Follow-Up Of Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up) (Thrive-IVF F/U)
Pregnancy, Delivery, And Neonatal Outcomes In Subjects With Ongoing Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
NT-04 is a follow-up study that will include subjects who received at least one dose of study drug and maintain ongoing clinical pregnancies through Week 10 of gestation during NT-03. NT-04 does not involve the administration of study drug treatment.
In NT-03, subjects who achieve an ongoing clinical pregnancy at Week 8 of gestation will undergo a repeat transvaginal ultrasound (TVU) at Week 10 of gestation (4 weeks after last dose of study drug). Subjects who are pregnant at Week 10 of gestation will be enrolled in NT-04.
Subjects in NT-04 will be contacted by telephone every 6 to 8 weeks until Week 38 of gestation, at which time subjects will be contacted every two weeks until confirmation of delivery. Information about pregnancy status and use of prescription medications will be collected at these telephone interviews.
Between Weeks 18 and 22 of gestation, an obstetrical ultrasound will be performed.
Following delivery, additional information will be obtained, including pregnancy outcome, gestational age at delivery, etc. Standardized photographs will be taken as part of a newborn assessment.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- At least one dose of study drug administered in NT-03
- Ongoing clinical pregnancy at Week 10 of gestation
- Able and willing to enroll in NT-04
Exclusion Criteria:
• None
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Follow-Up after dosing with NT100 Dose 1
|
|
Eksperimentel: Follow-Up after dosing with NT100 Dose 2
|
|
Placebo komparator: Follow-Up after dosing with Placebo
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of live births
Tidsramme: Within approximately 7 months after NT-03
|
Within approximately 7 months after NT-03
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of stillbirths
Tidsramme: Within approximately 7 months after study NT-03
|
Within approximately 7 months after study NT-03
|
Number of spontaneous abortions (miscarriages)
Tidsramme: Within approximately 7 months after study NT-03
|
Within approximately 7 months after study NT-03
|
Number of congenital anomalies
Tidsramme: Up to 4 weeks after birth
|
Up to 4 weeks after birth
|
Number of severe neonatal adverse events
Tidsramme: Up to 4 weeks after birth
|
Up to 4 weeks after birth
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- NT-04
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