A Modernized Approach to Prenatal Care in Low Risk Women

Pre-eclampsia Clinical Trial

Official title:

A Modernized Approach to Prenatal Care in Low Risk Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606774
• Other study ID #: PNC2.0
• Status: Completed
• Phase: N/A
• First received: May 24, 2012
• Last updated: February 3, 2017
• Start date: July 2012
• Est. completion date: April 2014

Study information

• Verified date: February 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Eclampsia
• Fetal Growth Retardation
• Intrauterine Growth Retardation
• Pre-eclampsia

Intervention

Other:
• Modernized prenatal care
Home monitoring/phone surveillance/28 week ultrasound in place of 4-5 routine prenatal visits between 18 and 36 weeks

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Nicolaides KH. A model for a new pyramid of prenatal care based on the 11 to 13 weeks' assessment. Prenat Diagn. 2011 Jan;31(1):3-6. doi: 10.1002/pd.2685. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unanticipated pregnancy complications	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	Gestational age 18-36 weeks