Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061570) titled 'Promotion of respectful childbirth in Mongolia: an exploratory study of the effects of facility-based intervention in a large public maternity hospital' on May 14.
Study Type:
Interventional
Study Design:
Basic Design - n-of-1
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Institute of Medicine, University of Tsukuba
Condition:
Condition - Childbearing women
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To explore the effect of continuous support by midwifery students to a small group of labouring women on their childbirth experience and birth outcomes
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - In addition to usual clinical care during labor and delivery, women receive continuous physical and emotional care services from midwifery students trained in doula support. The doula support was provided over 6 weeks and 24/7 hours. The ratio of student doulas and women was 1:4 and 1:2 in labor and delivery rooms, respectively. Regardless of eligibility for the study, all women delivered during the intervention period at the hospital received the intervention.
Interventions/Control_2 - usual clinical routine care
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Female
Key inclusion criteria - Uncomplicated singleton and cephalic presentation pregnancy, with spontaneous labor onset at gestational age 37 to 41 weeks, and women who were admitted during the active phase of the first stage of labor at cervical dilation of 4cm and more.
Key exclusion criteria - Multiple pregnancies, previous cesarean delivery, induced labor, cesarean delivery, severe pregnancy complication, severe maternal and newborn outcomes, preterm birth, low birth weight, and admission to ICU
Target Size - 840
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2019 Year 05 Month 14 Day
Date of IRB - 2019 Year 08 Month 28 Day
Anticipated trial start date - 2019 Year 10 Month 03 Day
Last follow-up date - 2020 Year 01 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060803
Disclaimer: Curated by HT Syndication.