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Investigating the impact of continuous midwifery care on socially vulnerable women

Implementation and evaluation of the effectiveness of the continuous midwifery care model in socially vulnerable women: a randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120718010324N84
Enrollment
92
Registered
2025-08-23
Start date
2025-09-11
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal care and high-risk pregnancies.

Interventions

Intervention 1: Intervention group: Participants in the intervention group will receive continuous midwifery care from the 14th week of pregnancy until 6 weeks after delivery by a permanent midwife (r

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women with vulnerable conditions (violence or poverty or unplanned pregnancy). Gestational age 12-14 weeks Possibility of participants attending (depending on location) in antenatal and postnatal group sessions at health centers. Nulliparous women or with a history of vaginal delivery Possibility of access to a smartphone Literacy (at least fifth grade education) Willingness to give birth in Bonab city

Exclusion criteria

Exclusion criteria: Multiple pregnancy History of cesarean delivery Major fetal anomalies Medical comorbidities History of high-risk pregnancy (stillbirth, recurrent miscarriage, preeclampsia, etc.)

Design outcomes

Primary

MeasureTime frame
Mean score of pregnancy experience. Timepoint: At 34–36 weeks of gestation. Method of measurement: Pregnancy Experience Scale (PES).;Mean score of childbirth experience. Timepoint: At 4–6 weeks postpartum. Method of measurement: Childbirth experience questionnaire version 2.0 (CEQ2.0):.;Depression scores at both time points, while controlling for baseline levels. Timepoint: At 34-36 weeks of pregnancy and 4-6 weeks after delivery. Method of measurement: Edinburgh postnatal depression scale (EPDS).

Secondary

MeasureTime frame
Frequency of type of delivery (cesarean section and vaginal delivery). Timepoint: After birth. Method of measurement: Maternal and neonatal outcome checklist.;Average length of labor stages (active, second, and third phases). Timepoint: In labour. Method of measurement: Maternal and neonatal outcome checklist.;Average length of hospitalization until delivery. Timepoint: From hospitalization to delivery. Method of measurement: Maternal and neonatal outcome checklist.;Average score of satisfaction with care. Timepoint: After completing the intervention in 36-39 weeks of pregnancy. Method of measurement: Visual Analogue Scale.;Average lactation performance score. Timepoint: At 4-6 weeks postpartum. Method of measurement: Breastfeeding performance questionnaire.;Average score of fear of childbirth. Timepoint: After birth. Method of measurement: (W-DEQ= The Wijma Delivery Experience Questionnaire version B).;Average specific anxiety score. Timepoint: At 4-6 weeks postpartum. Method of measurement: Postpartum specific anxiety scale.;Frequency of desire to have more children. Timepoint: At 4-6 weeks postpartum. Method of measurement: Maternal and neonatal outcome checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Ahadi- yulghunlu

Tabriz University of Medical Sciences

fatemehahadi8@gmail.com+98 914 496 5317

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 21, 2026