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)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Follow-Up after dosing with NT100 Dose 1
|
|
|
Experimentell: Follow-Up after dosing with NT100 Dose 2
|
|
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Placebo-jämförare: Follow-Up after dosing with Placebo
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Number of live births
Tidsram: Within approximately 7 months after NT-03
|
Within approximately 7 months after NT-03
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Number of stillbirths
Tidsram: Within approximately 7 months after study NT-03
|
Within approximately 7 months after study NT-03
|
|
Number of spontaneous abortions (miscarriages)
Tidsram: Within approximately 7 months after study NT-03
|
Within approximately 7 months after study NT-03
|
|
Number of congenital anomalies
Tidsram: Up to 4 weeks after birth
|
Up to 4 weeks after birth
|
|
Number of severe neonatal adverse events
Tidsram: Up to 4 weeks after birth
|
Up to 4 weeks after birth
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- NT-04
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