PostpartumPUnCTuALNCT03733405
Postpartum Care Timing: A Randomized Trial
A study testing Postpartum Visit at 6 Weeks and Postpartum Visit at 2 Weeks in people with Postpartum and Pregnancy Related, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum, Pregnancy Related
- What is being tested?
- Postpartum Visit at 6 Weeks and Postpartum Visit at 2 Weeks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairment, psychiatric instability, or language barriers that limit her ability to provide informed consent
- Plans to received postpartum care at other institution
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90095
About this study
Official title: Randomized Control Trial of Postpartum Visits at Two or Six Weeks to Evaluate Clinic Attendance and Emergency Department Usage
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.
Read the 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.
- Conditions
- Postpartum, Pregnancy Related
- Being tested
- Postpartum Visit at 6 Weeks, Postpartum Visit at 2 Weeks
- Keywords
- Breastfeeding, Contraception, Emergency, Department
- Medical subject headings
- Breast Feeding, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum Visit at 6 WeeksBehavioural
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.
Postpartum Visit at 2 WeeksBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Postpartum Visit 6 Weeks | Experimental | Participants will have a postpartum visit scheduled 6 weeks after birth Receives: Behavioral: Postpartum Visit at 6 Weeks |
| Postpartum Visit 2 and 6 Weeks | Experimental | Participants will have postpartum visits scheduled 2 and 6 weeks after birth Receives: Behavioral: Postpartum Visit at 6 Weeks; Behavioral: Postpartum Visit at 2 Weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance at one or more routine postpartum visits
The primary outcome will be the attendance at one or more scheduled postpartum visits at the clinic where the patient received her prenatal care.
Measured: 8 weeks postpartum
Secondary outcomes (1)
Rate of Emergency Department usage within 30 days of delivery
The secondary outcome will be the presentation and usage of an Emergency Department during the 30 days since delivery of the baby.
Measured: 30 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start31 Oct 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PostpartumStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilina Datkhaeva, University of California, Los Angeles
- Investigators
- Ilina Datkhaeva, MD, Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733405
- Sponsor's protocol ID
- 18-001453
- Acronym
- PUnCTuAL
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pluym ID, Tandel MD, Kwan L, Mok T, Holliman K, Afshar Y, Rao R. Randomized control trial of postpartum visits at 2 and 6 weeks. Am J Obstet Gynecol MFM. 2021 Jul;3(4):100363. doi: 10.1016/j.ajogmf.2021.100363. Epub 2021 Mar 27.
PubMed 33785465
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Postpartum Visits at Two or Six Weeks to Evaluate Clinic Attendance and Emergency Department Usage
- ClinicalTrials.gov ID
- NCT03733405
- Acronym / sponsor ID
- PUnCTuAL / 18-001453
- Conditions
- Postpartum, Pregnancy Related
- Keywords
- Breastfeeding, Contraception, Emergency, Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postpartum Visit 6 Weeks | Experimental | Behavioral: Postpartum Visit at 6 WeeksParticipants will have a postpartum visit scheduled 6 weeks after birth |
| Postpartum Visit 2 and 6 Weeks | Experimental | Behavioral: Postpartum Visit at 6 Weeks, Behavioral: Postpartum Visit at 2 WeeksParticipants will have postpartum visits scheduled 2 and 6 weeks after birth |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitive impairment, psychiatric instability, or language barriers that limit her ability to provide informed consent
- Plans to received postpartum care at other institution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postpartum Visit at 6 WeeksThe 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. | Behavioural | Postpartum Visit 2 and 6 Weeks, Postpartum Visit 6 Weeks |
| Postpartum Visit at 2 WeeksThe 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. | Behavioural | Postpartum Visit 2 and 6 Weeks |
Primary outcome
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.
1 secondary outcome
Rate of Emergency Department usage within 30 days of delivery
Time frame: 30 days postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 33785465Pluym ID, Tandel MD, Kwan L, Mok T, Holliman K, Afshar Y, Rao R. Randomized control trial of postpartum visits at 2 and 6 weeks. Am J Obstet Gynecol MFM. 2021 Jul;3(4):100363. doi: 10.1016/j.ajogmf.2021.100363. Epub 2021 Mar 27.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilina Datkhaeva, MD study director
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postpartum Visit at 6 Weeks and Postpartum Visit at 2 Weeks in people with Postpartum and Pregnancy Related, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance at one or more routine postpartum visits (time frame: 8 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03733405, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.