Effects of One-to-one Service on the Continuation and Satisfaction of Contraceptive Use.
- Conditions
- Contraceptive UsageContraception Behavior
- Interventions
- Other: Family Planning ServiceOther: One-to-one Service
- Registration Number
- NCT05362019
- Lead Sponsor
- National Research Institute for Family Planning, China
- Brief Summary
This study aims to explore the impact of a mobile based one-to-one service model on improving the continuation and satisfaction of combined injectable contraceptive use, and improve the utilization and acceptability of efficient and long-term contraceptive methods.
- Detailed Description
In China, due to the lack of understanding or misunderstanding of hormonal contraception by service providers and the public, the use of combined injectable contraceptive is not common. Therefore, this study aims to explore the impact of a mobile based one-to-one service model on improving the continuation and satisfaction of combined injectable contraceptive use, and improve the utilization and acceptability of efficient and long-term contraceptive methods.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 400
- 18 to 40 years old;
- Healthy Volunteers;
- More than 6 months after delivery and without lactation;
- No fertility intention within 6 months;
- Normal menstruation;
- No contraindications to the use of compound contraceptive methods;
- Had not used hormonal contraception in the previous three months;
- Understand the content and requirements of the project, be willing to cooperate, and have signed the informed consent form;
- Have a certian education level, and be able to use the special sanitary napkins to record menstrual volume and menstrual card.
- Suffering from serious systemic diseases;
- Previous or current thrombotic disease;
- Malignant tumor of uterine organ;
- Unable to communicate normally due to disability or mental or intellectual impairment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention group Compound Norethisterone Enanthate Injection A mobile phone based "service system" developed by the research group will be used to provide one-to-one service for the intervention group. control group Family Planning Service Routine family planning services will be provided to the control group. control group Compound Norethisterone Enanthate Injection Routine family planning services will be provided to the control group. intervention group One-to-one Service A mobile phone based "service system" developed by the research group will be used to provide one-to-one service for the intervention group.
- Primary Outcome Measures
Name Time Method Termination rate 6 months The termination rates of the two groups were observed for 6 months.
Continuation rate 6 months The continuation rates of the two groups were observed for 6 months.
Satisfaction rates Up to 4 weeks The satisfaction rates of two groups after a 6 months of contraceptive use.
- Secondary Outcome Measures
Name Time Method Complaint of adverse reactions Up to 9 months Complaint rates of various adverse reactions (dizziness / breast swelling / nausea) during different follow-up time.
Vaginal bleeding pattern Up to 9 months Collecting the vaginal bleeding patterns (including menstrual onset time, duration, and termination time) in two phases (90 days in each phase) and amount of menstrual bleeding at 3 months of use by using a self-developed questionnarie and special sanitary pads for measurement.
Dysmenorrhea Up to 9 months Dysmenorrhea will be collacted by a self-developed questionnarie (on a 10-point scale). A higher score indicated higher level of pain.
Waist and abdomen pain related to gynecology Up to 9 months The pain will be collacted by a self-developed questionnarie (on a 10-point scale). A higher score indicated higher level of pain.
Sexual intercourse pain Up to 9 months The pain will be collacted by a self-developed questionnarie (on a 10-point scale). A higher score indicated higher level of pain.
Trial Locations
- Locations (8)
Qinghai Red Cross Hospital
🇨🇳Xining, Qinghai, China
Tianjin Central Hospital of Gynecology Obstetrics
🇨🇳Tianjin, Tianjin, China
Yunnan Xishuangbanna people's Hospital
🇨🇳Xishuangbanna, Yunnan, China
Tianjin Jinnan hospital
🇨🇳Tianjin, Tianjin, China
Yunnan Xishuangbanna maternal and Child Health Hospital
🇨🇳Xishuangbanna, Yunnan, China
Qinghai People's Hospital
🇨🇳Xining, Qinghai, China
Tianjin Dongli hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University second hospital
🇨🇳Tianjin, Tianjin, China