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Effectiveness of Shortened Time Interval to Postpartum Visit in Improving Postpartum Attendance

14. august 2017 oppdatert av: Virginia Commonwealth University
Due to potential to improve family planning, clinicians are increasingly interested in shortening the time to postpartum visits, but lack an evidence base to change policy.There are no studies that have examined the effectiveness of shortened interval to postpartum visit on attendance rate, contraception use, and rapid repeat of pregnancy (RROP). With this research, the investigators propose to conduct a randomized controlled trial (RCT) to examine the effect of reduced time interval to postpartum visit (3-4 weeks rather than 6-8 weeks) on postpartum visit attendance rate, contraceptive use, and RROP.

Studieoversikt

Detaljert beskrivelse

Postpartum care is an essential component of women's reproductive health. During this time, the health care provider and the new mother review the previous pregnancy course, assess the mother's wellbeing, and establish treatment plans for any ongoing problems. Prospective guidance is given for both the mother and the baby in areas such as breastfeeding, nutrition, depression screening, and perineal/vulvar care. However, one of the most important goals of the postpartum visit is to discuss the new mother's desire for future pregnancies and the interval she wishes before another pregnancy. Inadequate reproductive health planning may result in unintended or rapid repeat of pregnancy (RROP), clinically defined as a second pregnancy within 24 months of the end of a previous pregnancy. A short inter-pregnancy interval is a risk factor for poor pregnancy outcomes including stillbirth, early neonatal death, extreme preterm births, and babies born small for gestational age. Compared to women who conceived 18-23 months after a previous birth, women conceiving less than five months after a previous birth had increased third trimester bleeding, uterine infection, premature rupture of membranes, and maternal death.Central to these outcomes is the rate of postpartum contraception use.

In fact, research shows an association between a postpartum visit and use of a reliable contraceptive method after pregnancy.

The optimal time for postpartum visit may be 3-4 weeks post-delivery rather than 6-8 weeks post-delivery with regard to visit attendance and proactive management of reproductive health, including contraception and time intervals between pregnancies. The timing of the postpartum visits are also linked to economic outcomes and healthcare utilization; postpartum care that results in decreased RROP and unintended pregnancies will likely decrease healthcare costs associated with the adverse consequences of inadequate reproductive health planning. Despite the obvious potential benefits of a decreased interval between delivery and the postpartum visit, to date, there have been no studies to systematically compare the impact of postpartum visit timing on visit attendance, contraception use and, subsequently, RROP.

This study is designed to investigate the effect of reduced time interval to postpartum visit on postpartum visit attendance rate, contraceptive use, and RROP. Additionally, the study will assess the impact of the two visit schedules on these outcomes by race, providing critical information about high risk populations. Finally, this research will assess the cost effectiveness of the shortened postpartum visit schedule relative to the standard of care. In order to account for potential bias in increased attendance rate due to intervention effect, compensation and other factors, this study will also compare the effectiveness of shortened time interval to postpartum visit on postpartum attendance rate and contraceptive use to a historic cohort.

Studietype

Intervensjonell

Registrering (Faktiske)

364

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • at least 18 years of age
  • delivered vaginally a healthy, full-term (at least 37 weeks gestation) baby
  • received prenatal care services at the VCUMCV OB clinic
  • speak English
  • provide informed consent for study participation.

Exclusion Criteria:

  • cognitive impairment, psychiatric instability, or language barriers that limit their ability to provide informed consent
  • surgically sterilized
  • have complicated deliveries that require extended hospital stays
  • need early follow-up to monitor their conditions
  • any problems with infants such as preterm birth, admission to the Neonatal Intensive Care Unit (NICU), congenital malformations or respiratory problems that would require frequent clinic visits or prolonged hospital admissions for the infants.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Postpartum Visit 3-4 Weeks
Participants will have postpartum visit scheduled 3-4 weeks after birth
This visit will be the same as the standard of care postpartum visit, but it will be scheduled earlier.
Eksperimentell: Postpartum Visit 6-8 Weeks
Participants will have postpartum visit scheduled 6-8 weeks after birth
This standard of care postpartum visit will be scheduled for the standard time interval.
Andre navn:
  • Velferdstandard

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postpartum Clinic Attendance
Tidsramme: assessed at 12 weeks postpartum
To compare the effectiveness of 3-4 week and 6-8 week intervals to postpartum visit on improving the rate of postpartum visit attendance. The investigators hypothesize that study participants with postpartum visits scheduled 3-4 weeks after delivery will be more likely to attend visits than study participants scheduled for visits 6-8 weeks after delivery.
assessed at 12 weeks postpartum

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Contraception Use
Tidsramme: Assessed at 3, 6, 9, 12, & 18 month follow-ups
Compare the effectiveness of 3-4 week and 6-8 week intervals to postpartum visit on consistent contraceptive use
Assessed at 3, 6, 9, 12, & 18 month follow-ups
Rapid Repeat Pregnancy
Tidsramme: Assessed at 3, 6, 9, 12, & 18 month follow-ups
Compare the effectiveness of 3-4 week and 6-8 week intervals to postpartum visit on repeat pregnancy
Assessed at 3, 6, 9, 12, & 18 month follow-ups
Cost effectiveness
Tidsramme: 18 month postpartum
Compare overall cost of postpartum care
18 month postpartum

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Racial Differences
Tidsramme: baseline, postpartum, 3, 6, 9, 12, & 18 month follow-ups
Compare the effectiveness of 3-4 week and 6-8 week intervals to postpartum visit on reducing racial differences in postpartum visit attendance rates and contraceptive use. Specifically, the study team hypothesizes that the difference in postpartum visit attendance and consistent contraceptive use rates between AA and CA study participants will be lower among study participants with postpartum visits scheduled 3-4 weeks after delivery compared to study participants scheduled for visits 6-8 weeks after delivery.
baseline, postpartum, 3, 6, 9, 12, & 18 month follow-ups

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Saba W Masho, Virginia Commonwealth University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

18. november 2013

Primær fullføring (Faktiske)

3. mars 2016

Studiet fullført (Faktiske)

20. juni 2017

Datoer for studieregistrering

Først innsendt

8. mai 2017

Først innsendt som oppfylte QC-kriteriene

23. mai 2017

Først lagt ut (Faktiske)

24. mai 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. august 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. august 2017

Sist bekreftet

1. august 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • HM20000032

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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