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IRCT20260722070300N1 IRCT 2026-08-01 Shiraz University of Medical Sciences Examining effect of a companion midwife on Fear of Childbirth and labor Satisfaction,and Subsequent Fertility Intention Examining effect of a companion midwife on Fear of Childbirth and labor Satisfaction,and Subsequent Fertility Intention Among Pregnant Womenreferring to selected hospitals of Shiraz University of Medical Sciences: A randomized clinical trial 2026-08-22 anticipated 68 Recruiting https://irct.ir/trial/91908 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: A total of 68 eligible nulliparous pregnant women will be enrolled after providing written informed consent and completing the baseline assessment. Participants will be randomly allocated in a 1:1 ratio to either the intervention group (n = 34), receiving continuous support from a companion midwife during labour and childbirth in addition to routine care, or the control group (n = 34), receiving routine maternity care only. Block randomization with a fixed block size of four will be used to ensure balanced allocation between the two study groups throughout the recruitment period. The unit of randomization is the individual participant. No cluster or stratified randomization will be applied. The random allocation sequence will be generated before participant recruitment using a computerized random sequence generator by an independent researcher who is not involved in participant recruitment, intervention delivery, or outcome assessment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes (SNOSE). After confirming eligibility, obtaining written informed consent, and completing participant enrolment, the corresponding envelope will be opened sequentially to reveal the group assignment. Therefore, the researcher responsible for participant recruitment will remain unaware of the allocation sequence until enrolment has been completed. N/A Fear of Childbirth and ,labor Satisfaction,and Subsequent Fertility Intention. Intervention 1: Intervention group: Participants in the intervention group will receive routine hospital maternity care in addition to continuous support from a trained companion midwife throughout the active phase of labor until childbirth. The companion midwife will provide emotional, informational, and physical support, including encouragement, reassurance, breathing guidance, assistance with maternal positioning, massage, and other non-pharmacological pain relief measures. Intervention 2: Control group: Participants in the control group will receive routine standard intrapartum care according to the hospital protocol and will not receive continuous support from a companion midwife. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No additional information is available
public Zahra Moradi
Ahura Buildin,Ally 2,Shimigiah street
Shiraz Iran (Islamic Republic of) 718885495 +98 71 3654 4759 momymidwife@gmail.com Shiraz University of Medical Sciences scientific Zahra Moradi
Ahura Buildin,Ally 2,Shimigiah street
Shiraz Iran (Islamic Republic of) 718885495 +98 71 3654 4759 momymidwife@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iranian nationality Willingness to participate voluntarily in the study and provision of written informed consent Maternal age between 18 and 40 years Ability to read and write minimum literacy Singletonand and planned pregnancy Gestational age between 37 and 42 weeks Spontaneous onset of labor Cephalic fetal presentation 18 years 40 years Female No history of physical illnesses or psychiatric disorders that could interfere with the labor process No use of psychiatric medications or illicit drugs including both traditional and synthetic substances Behavior Behavior Intervention group: Participants in the intervention group will receive routine hospital maternity care in addition to continuous support from a trained companion midwife throughout the active phase of labor until childbirth. The companion midwife will provide emotional, informational, and physical support, including encouragement, reassurance, breathing guidance, assistance with maternal positioning, massage, and other non-pharmacological pain relief measures Control group: Participants in the control group will receive routine standard intrapartum care according to the hospital protocol and will not receive continuous support from a companion midwife. Fear of Childbirth. Timepoint: Baseline before the intervention, prior to the onset of labour and 24–48 hours after childbirth. Method of measurement: Hartmann Childbirth Attitude Questionnaire. Childbirth satisfaction. Timepoint: At 12 to 24 hours postpartum. Method of measurement: Mackey Childbirth Satisfaction. Childbearing intention. Timepoint: At 6 weeks postpartum. Method of measurement: Attitudes toward Fertility and Childbearing Scale. Shiraz University of Medical Sciences Approved 1994-02-01 Ethics committee of Shiraz University of Medical Sciences Unit 6, Ahura Building, Alley 2, Shimi Giah Street Shiraz Fars Iran (Islamic Republic of)