Efficacy of a midwife-coordinated, individualized, and specialized maternity care intervention (ChroPreg) in addition to standard care in pregnant women with chronic disease: protocol for a parallel randomized controlled trial

Abstract

Background and objectives The number of women of childbearing age with chronic diseases is rising. Evidence has shown that obstetric complications and poor psychological well-being are more prevalent among this group, in addition to these women reporting experiences of less than satisfactory care. More research is needed to investigate how to best meet the special needs of this group during pregnancy and postpartum. Previous research has shown that care coordination, continuity of care, woman-centered care, and specialized maternity care interventions delivered to women with high-risk pregnancies can improve patient-reported outcomes and pregnancy outcomes and be cost-effective. However, no previous trials have examined the efficacy and cost-effectiveness of such interventions among pregnant women with chronic diseases. This paper describes the protocol of a randomized controlled trial (RCT) of a midwife-coordinated, individualized and specialized maternity care intervention (ChroPreg) as an add-on to standard care for pregnant women with chronic diseases. Methods/design This two-arm parallel group RCT will be conducted from October 2018 through June 2020 at the Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Denmark. Pregnant women with chronic diseases are invited to participate; women will be randomized and allocated 1:1 to the ChroPreg intervention plus standard care or standard care alone. The ChroPreg intervention consists of three main components: (1) coordinated and individualized care, (2) additional ante- and postpartum consultations, and (3) specialized midwives. The primary outcome is length of hospital stay during pregnancy and in the postpartum period, and secondary outcomes are psychological well-being (five-item World Health Organization Well-Being Index, Edinburgh Postnatal Depression Scale, Cambridge Worry Scale), health-related quality of life (12-Item Short Form Health Survey), patient satisfaction (Pregnancy and Childbirth Questionnaire), number of antenatal contacts, and pregnancy and delivery outcomes. Data are collected via patient-administered questionnaires and medical records. Discussion This trial is anticipated to contribute to the field of knowledge on which planning of improved antenatal, intra-, and postpartum care for women with chronic disease is founded. Trial registration ClinicalTrials.gov, NCT03511508 . Registered April 27, 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3405-5) contains supplementary material, which is available to authorized users.

Effects of a Midwife-Coordinated Maternity Care Intervention (ChroPreg) vs. Standard Care in Pregnant Women with Chronic Medical Conditions: Results from a Randomized Controlled Trial

“…This trial used a two-arm parallel-group randomized trial design (1:1). The methods applied and a detailed description of the intervention have been published previously [25]. The reporting of the trial follows the CONSORT guidelines [26].…”

“…The reporting of the trial follows the CONSORT guidelines [26]. No changes were made to the intervention or prespecified outcomes outlined in the original study protocol [25]. The trial was registered at ClinicalTrials.gov on 27 April 2018 (NCT03511508).…”

“…Postpartum follow-up in the weeks after birth and a face-to-face postpartum debriefing session to facilitate evaluation and processing of the childbearing and birth experience were also planned [32]. To ensure flexibility and individualization of care, unlimited access to e-mail consultations and weekly telephone hours were available (Supplementary Materials Table S1 and the study protocol [25]).…”

Probiotics as Potential Antimicrobials for the Treatment of Infections: Current Reality or Remote Future?

“…Probiotics appear to prevent recurrent urinary infections by contributing to the recovery and maintenance of microbiomes, by reducing the adherence, growth, and colonization of infectious pathogens in the urinary tract, in addition to improving host defenses, and attenuating or eliminating inflammation [105,[134][135][136][137][138][139][140][141][142][143][144]. Unlike the beneficial role of the use of probiotics in preventing urinary infections in children [132], it appears to have no protective effect in adults with severe spinal injuries, who have recurrent urinary infections [145], as well as in healthy young women [146].…”

Risk, Prevention and Management of Complications After Vaginal and Caesarean Section Birth

“…While birth rates are falling in high-income countries, 11 the greatest challenge for low middleincome countries (LMICs) with high birth rates is to provide good quality care within the economic climate of the nation. 12 Furthermore, with the rising number of women of childbearing age with chronic diseases, obstetric complications and poor psychological wellbeing is becoming more prevalent, 13 demanding care from a multidisciplinary team of specialists. Complications, both physical and psychological can arise as a consequence of the birth itself, whether by vaginal delivery or by caesarean section.…”