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Postpartum Care Timing: A Randomized Trial (PUnCTuAL)

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ClinicalTrials.gov Identifier: NCT03733405
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ilina Datkhaeva, University of California, Los Angeles

Brief Summary:
The purpose of this study is to determine if shortening the time to initial postpartum visit from six weeks to two weeks can improve clinic visit attendance and decrease usage of the emergency department.

Condition or disease Intervention/treatment Phase
Postpartum Pregnancy Related Behavioral: Postpartum Visit at 6 Weeks Behavioral: Postpartum Visit at 2 Weeks Not Applicable

Detailed Description:
Postpartum care is an integral component to completing the maternal peripartum experience and transitioning the patient to well-women care. The American Congress of Obstetrics and Gynecology has recently highlighted the importance of this "fourth stage" of pregnancy suggesting earlier and more comprehensive visits compared to the standard 6-week postpartum visit. Specifically they describe that "all women should ideally have contact with a maternal care provider within the first three weeks postpartum" however this is largely derived from expect opinion and retrospective data. The current rate of postpartum visit attendance is as low as 66%, especially in women with scant prenatal care. In the investigators government-funded clinic, the postpartum clinic attendance in 2017 was 69% and many of the patients have co-morbidities, notably a 25% rate of psychiatric illness. Additionally, in this population, the investigators have identified a high rate of Emergency Department (ED) usage (8.7%) within 30 days of delivery suggesting that perhaps an earlier routine visit is ideal and can prevent the use of the ED. The aim therefore is to evaluate the utility of an early postpartum visit at two weeks in addition to a standard six-week visit with a randomized control trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Control Trial of Postpartum Visits at Two or Six Weeks to Evaluate Clinic Attendance and Emergency Department Usage
Actual Study Start Date : October 31, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
Experimental: Postpartum Visit 6 Weeks
Participants will have a postpartum visit scheduled 6 weeks after birth
Behavioral: Postpartum Visit at 6 Weeks
The patient will be scheduled for a routine postpartum visit at the standard time interval. Each postpartum visit will consist of the standard interview and physical examination. The purpose of this visit is for routine postpartum care. If she has a medical complication during delivery, she may be recommended to schedule an additional earlier visit.

Experimental: Postpartum Visit 2 and 6 Weeks
Participants will have postpartum visits scheduled 2 and 6 weeks after birth
Behavioral: Postpartum Visit at 6 Weeks
The patient will be scheduled for a routine postpartum visit at the standard time interval. Each postpartum visit will consist of the standard interview and physical examination. The purpose of this visit is for routine postpartum care. If she has a medical complication during delivery, she may be recommended to schedule an additional earlier visit.

Behavioral: Postpartum Visit at 2 Weeks
The patient will be scheduled for an earlier postpartum visit in addition to the standard time interval. Each postpartum visit will consist of the standard interview and physical examination. The purpose of this visit is for routine postpartum care. If she has a medical complication during delivery, she may be recommended to schedule an additional earlier visit.




Primary Outcome Measures :
  1. Attendance at one or more routine postpartum visits [ Time Frame: 8 weeks postpartum ]
    The primary outcome will be the attendance at one or more scheduled postpartum visits at the clinic where the patient received her prenatal care.


Secondary Outcome Measures :
  1. Rate of Emergency Department usage within 30 days of delivery [ Time Frame: 30 days postpartum ]
    The secondary outcome will be the presentation and usage of an Emergency Department during the 30 days since delivery of the baby.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Receives antepartum, intrapartum and postpartum care at UCLA
  • Speaks English or Spanish
  • Provides informed consent for study participation
  • Vaginal, cesarean delivery or operative vaginal delivery

Exclusion Criteria:

  • Cognitive impairment, psychiatric instability, or language barriers that limit her ability to provide informed consent
  • Plans to received postpartum care at other institution

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733405


Contacts
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Contact: Ilina Datkhaeva, MD (310) 206-6558 idatkhaeva@mednet.ucla.edu

Locations
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United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Ilina Datkhaeva    310-206-6558    idatkhaeva@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Study Director: Ilina Datkhaeva, MD University of California, Los Angeles

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Responsible Party: Ilina Datkhaeva, Co-principal investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03733405     History of Changes
Other Study ID Numbers: 18-001453
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ilina Datkhaeva, University of California, Los Angeles:
Breastfeeding
Contraception
Emergency
Department