Informed Consent for Episiotomy
Conditions
Interventions
Women in the qualitative interview group:None
Midwives in the qualitative interview group:None
Women, midwives, and doctors in the qualitative interview group:None
Preliminary group:1. Preparation Phase
Study period: From 36 weeks’ gestation until admission
Study locations: Obstetrics outpatient clinics, antenatal classes
Study personnel: Midwives, nurses
Study
Sponsors
Luoyang Maternal and Child Health Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Quantitative study (1) Inclusion criteria: 1) Women who have given birth vaginally at =36 weeks’ gestation; 2) Women aged =18 years, with a height >145 cm, who possess full legal capacity and are able to understand the study content; 3) Women who are able to read independently or complete the questionnaire with the assistance of a researcher; 4) Women who voluntarily participate in this study and sign an informed consent form. 2. Qualitative study (1) Mothers (qualitative interview participants) Inclusion criteria: 1) Gestational age = 36 weeks, mothers who have undergone vaginal delivery; 2) Age = 18 years, height > 145 cm, possessing full legal capacity; 3) Willing to share their delivery experiences and experiences regarding informed consent for episiotomy; 4) Able to understand the interview content and express themselves effectively; 5) Voluntarily participating in the study and signing an informed consent form. (2) Healthcare Professionals Inclusion criteria: 1) Healthcare professionals working in obstetrics (including obstetricians and midwives); 2) With =1 year of relevant clinical experience; 3) Able to participate in practices or discussions related to informed consent for episiotomy; 4) Able to understand the content of interviews or focus group discussions and clearly express their views; 5) Willing to participate in the study and sign an informed consent form. 3. Intervention Trial (1) Inclusion criteria: 1) Pregnant women at =36 weeks’ gestation planning a vaginal delivery; 2) Aged =18 years, height >145 cm, and possessing full legal capacity; 3) Singleton, cephalic presentation pregnancy; 4) Possessing basic communication skills and able to understand and cooperate with the study procedures; 5) Voluntarily participating in the study and signing an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Quantitative study (1) Exclusion criteria: 1) Those who have undergone a caesarean section or for whom there are medical indications necessitating an episiotomy; 2) Those with severe pregnancy complications or medical or surgical conditions that may affect the mode of delivery or the questionnaire assessment; 3) Those with mental illness or cognitive impairment who are unable to understand the content of the questionnaire; 4) Those with severe language or communication difficulties who are unable to complete the questionnaire; 5) Those participating in other clinical trials that may influence the results of this study. 2. Exclusion Criteria for Qualitative Research Participants (1) Mothers 1) Those with severe mental illness or cognitive impairment who are unable to understand the interview content or express themselves effectively; 2) Those with significant language or communication barriers who are unable to complete the interview; 3) Those unable to cooperate in completing the interview due to physical condition or other reasons; 4) Those unable to guarantee their availability for the interview or who are likely to withdraw midway. (2) Healthcare Professionals 1) Those unable to guarantee availability for interviews or focus group discussions; 2) Those with limited expressive or communicative abilities, rendering them unable to complete a meaningful interview; 3) Those unable to maintain consistent participation throughout the study or with a high likelihood of withdrawing midway; 4) Those with other factors that may compromise the authenticity of the interview or the integrity of the discussion. 3. Intervention Trial Participants (3) Exclusion Criteria: 1) Those with clear medical indications requiring an episiotomy or who are unable to make independent decisions regarding childbirth; 2) Those confirmed to require a caesarean section; 3) Those with severe pregnancy complications or serious medical or surgical conditions; 4) Those with mental illness or cognitive impairment who are unable to understand the study content; 5) Those with language or communication barriers who are unable to cooperate in completing the intervention and assessment; 6) Those participating in other studies that may interfere with the results of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Episiotomy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of perineal injury;Rate of intact perineum; | — |
Countries
China
Contacts
Public ContactLi Dan
Luoyang Maternal and Child Health Hospital
Outcome results
None listed