Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05745896
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-27
First Post:
2022-07-31
Brief Title:
A Telemedicine Prenatal Care Model on Low Risk Pregnants The mMae-e Study
Sponsor:
Talita Colombo
Organization:
Federal University of Health Science of Porto Alegre
Study Overview
Official Title:
A Telemedicine Prenatal Care Model on Low Risk Pregnants An Effectiveness Randomized Clinical Trial The mMae-e Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mmae-e
Brief Summary:
This study will compare the effectiveness of a prenatal care supported by telemedicine against usual care in low-risk pregnant women The investigators will follow-up women in a gestational age of 6 weeks up to 41 weeks and 6 postpartum weeks The primary outcome is the anxiety level estimated by the General Anxiety Scale 7 scale GAD-7 Scale
Detailed Description:
This is a pragmatic effectiveness superiority randomized clinical trial RCT in which low risk pregnants will be randomized to a prenatal care program supported by telemedicine or usual care in an allocation ratio of 11 The follow-up period will last 41 weeks from inception ie 6 to 13 weeks of gestational age to pregnancy and a extension period of 6 weeks in the postpartum stage The investigators settled anxiety levels estimated by the General Anxiety Scale 7 scale as primary outcome in a between-groups mean difference after the 3rd trimester Secondary outcomes include delivery mode obstetric events and fetal and neonatal variables of epidemiological surveillance interest birth weight birth height and APGAR score maternal fetal and neonatal fatal and non-fatal events The interventions will occur as follows for usual care all appointments at least 9 outpatient clinic visits will be carried forward in person by a senior obstetrician Patients randomized for the telemedicine supported group should will attend at least 6 in person and 3 online appointments All pregnant women will receive the standardized care throughout the study The sample size calculation was based on the primary outcome assuming between-groups mean difference of 4 points plus a 4-points standard deviation at a statistical of 80 and a two-tailed 5 type I error Further a 15 of addition was done for potential impairments during the follow-up ending in 30 patients per group The mmae-e studys setting will be the at Santa Casa de Misericórdia Porto Alegre Brazil
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None