A Modernized Approach to Prenatal Care in Low Risk Women

Not Applicable

Completed

• Conditions: Pre-eclampsia; Intrauterine Growth Retardation
• Interventions: Other: Modernized prenatal care

• Registration Number: NCT01606774
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The investigators plan to identify 80 pregnant women at low risk for obstetrical complications and replace 4-5 routine third trimester visits with a structured program of home weight, blood pressure and urine protein monitoring along with regular structured phone interviews and a 28 week ultrasound. The investigators hypothesis is that this protocol is both safe and acceptable.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-25
• Study First Posted: 2012-05-28
• Study Start: 2012-07
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

• Age < 35
• Doesn't live alone
• Current phone number
• Previous pregnancy
• No prior second trimester miscarriage/fetal loss after 13 weeks
• Previous delivery
• If yes, all had uncomplicated antepartum course
• All Deliveries > 37 weeks
• All birth weight > 2700 grams
• Maternal BMI between 18.5 and 30
• No chronic medical problems
• No current substance abuse
• Spontaneous conception
• No family history of pre-eclampsia
• Agrees to first trimester aneuploidy screening

Exclusion Criteria

• Clinically significant abnormalities on routine physical exam or routine laboratory results
• Multiple pregnancy
• Fetal abnormalities detected on either the 11-14 week or the 18 week ultrasound including a nuchal translucency > 3 mm but not including second trimester markers for aneuploidy or a low lying placenta
• A risk of fetal aneuploidy on first trimester screening > 1:300 PAPP-A < 5 %ile or HCG < 1 %ile (abnormalities of these serum analytes routinely obtained as part of aneuploidy screening are associated with an increased risk of adverse outcome)
• Elevated blood pressure (> 140/90),
• Cervical length < 3 cm at the 18 week ultrasound (which is associated with an increased risk for preterm delivery).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low risk patients	Modernized prenatal care	Patients who agreed to 4 telemedicine obstetrical visits

Primary Outcome Measures

Name	Time	Method
Unanticipated pregnancy complications	Gestational age 18-36 weeks	Any maternal and/or fetal adverse outcome that was not detected, but could have been detected by routine antepartum visits between 18 and 36 weeks

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States