Dataset Information

Study protocol for a randomised trial evaluating the effect of a "birth environment room" versus a standard labour room on birth outcomes and the birth experience.

ABSTRACT:

Introduction

In the last decade, there has been an increased interest in exploring the impact of the physical birth environment on birth outcomes. The birth environment might have an important role in facilitating the production of the hormone oxytocin that causes contractions during labour. Oxytocin is released in a safe, secure and confidence-inducing environment, and environments focused on technology and medical interventions to achieve birth may disrupt the production of oxytocin and slow down the progress of labour. An experimental "birth environment room" was designed, inspired by knowledge from evidence-based healthcare design, which advocates bringing nature into the room to reduce stress. The purpose is to examine whether the 'birth environment room', with its design and decor to minimise stress, has an impact on birth outcomes and the birth experience of the woman and her partner.

Materials and methods

A randomised controlled trial will recruit 680 nulliparous women at term who will be randomly allocated to either the "birth environment room" or a standard room. The study will take place at the Department of Obstetrics and Gynecology at Herning Hospital, with recruitment from May 2015. Randomisation to either the "birth environment room" or standard room takes place just before admission to a birth room during labour. The primary outcome is augmentation of labour, and the study has 80% power to detect a 10% difference between the two groups (two-sided ??=?0.05). Secondary outcomes are duration of labour, use of pharmacological pain relief, mode of birth, and rating of the birth experience by women and their partners.

Trial registration

NCT02478385(10/08/2016).

SUBMITTER: Lorentzen I

PROVIDER: S-EPMC6402376 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Study protocol for a randomised trial evaluating the effect of a "birth environment room" versus a standard labour room on birth outcomes and the birth experience.

Lorentzen Iben I Andersen Charlotte Sander CS Jensen Henriette Svenstrup HS Fogsgaard Ann A Foureur Maralyn M Lauszus Finn Friis FF Nohr Ellen Aagaard EA

Contemporary clinical trials communications 20190215

<h4>Introduction</h4>In the last decade, there has been an increased interest in exploring the impact of the physical birth environment on birth outcomes. The birth environment might have an important role in facilitating the production of the hormone oxytocin that causes contractions during labour. Oxytocin is released in a safe, secure and confidence-inducing environment, and environments focused on technology and medical interventions to achieve birth may disrupt the production of oxytocin an ...[more]

PMID: 30886935

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Project description:ObjectiveIn the last decade, there has been an increased interest in exploring the impact of the physical birth environment on midwifery practice and women's birth experiences. This study is based on the hypothesis that the environment for birth needs greater attention to improve some of the existing challenges in modern obstetric practice, for example the increasing use of augmentation and number of interventions during delivery.Study designA randomized controlled trial was carried out to study the effect of giving birth in a specially designed "birth environment room" on the use of augmentation during labor. The study took place at the Department of Obstetrics and Gynecology, Herning Hospital, Denmark and included 680 nulliparous women in spontaneous labor at term with a fetus in cephalic presentation. Women were randomly allocated to either the "birth environment room" or a standard birth room. The primary outcome was augmentation of labor by use of oxytocin. Secondary outcomes were duration of labor, use of pharmacological pain relief, and mode of birth. Differences were estimated as relative risks (RR) and presented with 95% confidence intervals.ResultsNo difference was found on the primary outcome, augmentation of labor (29.1% in the "birth environment room" versus 30.6% in the standard room, RR 0.97; 0.89-1.08). More women in the "birth environment room" used the bathtub (60.6% versus 52.4%, RR 1.18; 1.02-1.37), whereas a tendency to lower use of epidural analgesia (22.6% versus 28.2%) did not reach statistical significance (RR 0.87; 0.74-1.02). The chance of an uncomplicated birth was almost similar in the two groups (70.6% in the "birth environment room" versus 72.6% in the standard room, RR 0.97; 0.88-1.07) as were duration of labor (mean 7.9 hours in both groups).ConclusionsBirthing in a specially designed physical birth environment did not lower use of oxytocin for augmentation of labor. Neither did it have any effect on duration of labor, use of pharmacological pain relief, and chance of birthing without complications. We recommend that future trials are conducted in birth units with greater improvement potentials.

Project description:BackgroundAn important prerequisite for optimal healthcare is a secure, safe and comfortable environment. There is little research on how the physical design of birthing rooms affects labour, birth, childbirth experiences and birthing costs. This protocol outlines the design of a randomised controlled superiority trial (RCT) measuring and comparing effects and experiences of two types of birthing rooms, conducted in one labour ward in Sweden.Methods/designFollowing ethics approval, a study design was developed and tested for feasibility in a pilot study, which led to some important improvements for conducting the study. The main RCT started January 2019 and includes nulliparous women presenting to the labour ward in active, spontaneous labour and who understand either Swedish, Arabic, Somali or English. Those who consent are randomised on a 1:1 ratio to receive care either in a regular room (control group) or in a newly built birthing room designed with a person-centred approach and physical aspects (such as light, silencer, media installation offering programmed nature scenes with sound, bathtub, birth support tools) that are changeable according to a woman's wishes (intervention group). The primary efficacy endpoint is a composite score of four outcomes: no use of oxytocin for augmentation of labour; spontaneous vaginal births (i.e. no vaginal instrumental birth or caesarean section); normal postpartum blood loss (i.e. bleeding < 1000 ml); and a positive overall childbirth experience (7-10 on a scale of 1-10). To detect a difference in the composite score of 8% between the groups we need 1274 study participants (power of 80% with significance level 0.05). Secondary outcomes include: the four variables in the primary outcome; other physical outcomes of labour and birth; women's self-reported experiences (the birthing room, childbirth, fear of childbirth, health-related quality of life); and measurement of costs in relation to the hospital stay for mother and neonate. Additionally, an ethnographic study with participant observations will be conducted in both types of birthing rooms.DiscussionThe findings aim to guide the design of birthing rooms that contribute to optimal quality of hospital-based maternity care.Trial registrationClinicalTrials.gov NCT03948815. Registered 13 May 2019-retrospectively registered.

Project description:BackgroundProlonged latent phase of labour often results in a traumatic birth experience. Prolonged labour is associated with more operative deliveries, haemorrhage, fetal asphyxia and poor birth experience. Women with prolonged labour in a former pregnancy more often demand caesarean section in the next, due to their negative birth experience. "Proactive support of labour" is an alternative method, developed to counteract prolonged labour. There are little research and no randomized controlled study that compare proactive to standard labour support.Methods/designA prospective, non-blinded, randomized, single-centre, clinical trial where we compare proactive support to standard support of labour in a university hospital setting.Inclusion criterialatent phase of labour, non-pathologic pregnancy. Robson group 1, with painful contractions, and fully effaced cervix, with 1-3 cm dilatation.Exclusion criteriainduction of labour, breech presentation, twin pregnancy, multi-parity, conditions that require extended surveillance before and/or during labour.Primary outcomespontaneous, uncomplicated vaginal delivery. After inclusion, women randomized to proactive support of labour will stay at the hospital and have one-to-one midwife support. If no progression during the next 1-2 hours, amniotomy and/or oxytocin stimulation will be started. The control group will adhere to the standard procedures for labour support: expectance until established regular contractions and 4-5 cm cervical dilatation, and then one-to-one midwife support.DiscussionThe idea of proactive support of labour is to initiate early intervention when there are signs of slow progress in order to avoid protracted labour with exhaustion of the mother, the uterus and prolonged stress of the foetus. Proactive support of labour may represent a useful method to improve labour support in nulliparous women. However, evidence based on randomized controlled trials are needed in order to know whether proactive support of labour is comparable or superior to standard care. A randomized, controlled trial is described; challenges and possible clinical implications are discussed.Trial registrationThe Proactive Support of Labor Study (PAF) ClinicalTrials, NCT03056313. Registered on February 17, 2017.

Project description:BACKGROUND:Many infants born at less than 34 weeks of gestational age will require resuscitation in the delivery suite. Yet, different resuscitation techniques are specified in different national guidelines, likely reflecting a limited evidence base. One difference is the length of mechanical inflation initially delivered to infants either via a facemask or endotracheal tube. Some guidelines specify short inflations delivered at rates of 40-60/min, others recommend initial inflations lasting 2-3 s or sustained inflations lasting for???5 s for initial resuscitation. Research has shown that tidal volumes?>?2.2 mL/kg (the anatomical dead space) are seldom generated unless the infant's respiratory effort coincides with an inflation (active inflation). When inflations lasting 1-3 s were used, the time to the first active inflation was inversely proportional to the inflation time. This trial investigates whether a sustained inflation or repeated shorter inflations is more effective in stimulating the first active inflation. METHODS:This non-blinded, randomised controlled trial performed at a single tertiary neonatal unit is recruiting 40 infants born at?<?34 weeks of gestational age. A 15-s sustained inflation is being compared to five repeated inflations of 2-3 s during the resuscitation at delivery. A respiratory function monitor is used to record airway pressure, flow, expiratory tidal volume and end tidal carbon dioxide (ETCO2) levels. The study is performed as emergency research without prior consent and was approved by the NHS London-Riverside Research Ethics Committee. The primary outcome is the minute volume in the first minute of resuscitation with secondary outcomes of the time to the first active inflation and ETCO2 level during the first minute of recorded resuscitation. DISCUSSION:This is the first study to compare a sustained inflation to the current UK practice of five initial inflations of 2-3 s. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02967562 . Registered on 15 November 2016.

Project description:INTRODUCTION:Migrant women consistently rate their care during labour and birth more negatively than non-migrant women, due to communication difficulties, lack of familiarity with how care is provided, and discrimination and prejudicial staff attitudes. They also report being left alone, feeling fearful, unsafe and unsupported, and have poorer birth outcomes than non-migrant women. Community-based doulas (CBDs) are bilingual women from migrant communities who are trained in childbirth and labour support, and who facilitate communication between woman-partner-staff during childbirth. This study protocol describes the design, rationale and methods of a randomised controlled trial that aims to evaluate the effectiveness of CBD support for improving the intrapartum care experiences and postnatal well-being of migrant women giving birth in Sweden. METHODS AND ANALYSIS:A randomised controlled trial. From six antenatal care clinics in Stockholm, Sweden, we aim to recruit 200 pregnant Somali, Arabic, Polish, Russian and Tigrinya-speaking women who cannot communicate fluently in Swedish, are 18 years or older and with no contraindications for vaginal birth. In addition to standard labour support, women are randomised to CBD support (n=100) or no such support during labour (n=100). Trained CBDs meet with women once or twice before the birth, provide emotional, physical and communication support to women throughout labour and birth in hospital, and then meet with women once or twice after the birth. Women's ratings of the intrapartum care experiences and postnatal well-being are assessed at 6-8 weeks after the birth using selected questions from the Migrant Friendly Maternity Care Questionnaire and by the Edinburgh Postnatal Depression Scale. The intervention group will be compared with the control group using intention-to-treat analyses. ORs and 95% CIs will be estimated and adjustments made if key participant characteristics differ between trial arms. ETHICS AND DISSEMINATION:The study was approved by the Regional Ethical Review Board in Stockholm (approval number: 2018/12 - 31/2). TRIAL REGISTRATION NUMBER:NCT03461640; Pre-results.

Project description:BackgroundPreterm labour and birth (PTL/PTB) is characterised by major health and developmental risks for children, life-changing consequences for their families, and substantial healthcare and economic challenges for wider society. While it is known that PTL/PTB impacts infant healthcare costs in the short and long term in Germany, maternal costs have not been described in detail. The aim of this study was to comprehensively describe costs and resource use among PTL/PTB mothers during pregnancy, at hospitalisation for delivery, and up to three years after delivery-overall and according to gestational age (GA) at delivery.MethodsThis study used data from the Statutory Health Insurance (SHI) sample of the AOK Hessen database in Germany. Mothers aged 12-44 years with deliveries between 2009 and 2013 and > 9 months of medical history prior to delivery were included. PTL/PTB mothers were defined by an International Classification of Diseases, 10th Revision (ICD-10) code for PTL during pregnancy, a diagnosis-related group (DRG) code indicating birthweight < 2500 g, or delivery of an infant < 37 weeks GA. Inpatient and outpatient resource use and total direct medical costs were examined during pregnancy, at delivery hospitalisation, and up to three years post-delivery.ResultsOf all mothers, 2147 (20%) experienced PTL/PTB. During pregnancy, median costs for PTL/PTB mothers were €2130. During delivery hospitalisation, the mean length of stay for all PTL/PTB mothers was 6.0 days, and median costs were €2037. Length of stay and costs declined with increasing GA. Long term, PTL/PTB mothers' total median costs were €607 in Year 1, €332 in Year 2, and €388 in Year 3 post-delivery. In each year after delivery, median costs appeared to be greater for mothers who delivered at lower GAs.ConclusionIn this description of costs and resource use among PTL/PTB mothers in Germany throughout the pregnancy and up to three years after delivery, the greatest costs were noted prior to delivery. Costs appeared to decrease with increasing GA, particularly during the delivery hospitalisation and the first year after delivery.

Dataset Information

Study protocol for a randomised trial evaluating the effect of a "birth environment room" versus a standard labour room on birth outcomes and the birth experience.

Introduction

Materials and methods

Trial registration

Publications

Study protocol for a randomised trial evaluating the effect of a "birth environment room" versus a standard labour room on birth outcomes and the birth experience.

Similar Datasets

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