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

14 août 2017 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

364

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Expérimental: 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.
Autres noms:
  • Norme de soins

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Postpartum Clinic Attendance
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Contraception Use
Délai: 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
Délai: 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
Délai: 18 month postpartum
Compare overall cost of postpartum care
18 month postpartum

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Racial Differences
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Saba W Masho, Virginia Commonwealth University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 novembre 2013

Achèvement primaire (Réel)

3 mars 2016

Achèvement de l'étude (Réel)

20 juin 2017

Dates d'inscription aux études

Première soumission

8 mai 2017

Première soumission répondant aux critères de contrôle qualité

23 mai 2017

Première publication (Réel)

24 mai 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 août 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 août 2017

Dernière vérification

1 août 2017

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • HM20000032

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Postpartum Visit 3-4 Weeks

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