Effects of One-to-one Service on the Continuation and Satisfaction of Contraceptive Use.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of One-to-one Service on the Continuation and Satisfaction of Combined Injectable Contraceptive Use.

Conditions
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Contraception Behavior, Contraceptive Usage

Intervention / Treatment
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* Drug: Compound Norethisterone Enanthate Injection
* Other: One-to-one Service
* Other: Family Planning Service


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>A mobile phone based service system developed by the research group will be used to provide one-to-one service for the intervention group. | Drug: Compound Norethisterone Enanthate Injection<br>* Combined injectable contraceptive use<br>Other: One-to-one Service<br>* A mobile phone based service system will be used to pushing contraceptive knowledges, reminding injection, providing consultation on adverse reactions and ect.<br>|
| Active Comparator: control group<br>Routine family planning services will be provided to the control group. | Drug: Compound Norethisterone Enanthate Injection<br>* Combined injectable contraceptive use<br>Other: Family Planning Service<br>* routine family planning service and contraceptive service.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Termination rate | The termination rates of the two groups were observed for 6 months. | 6 months | 
| Continuation rate | The continuation rates of the two groups were observed for 6 months. | 6 months | 
| Satisfaction rates | The satisfaction rates of two groups after a 6 months of contraceptive use. | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complaint of adverse reactions | Complaint rates of various adverse reactions (dizziness / breast swelling / nausea) during different follow-up time. | Up to 9 months | 
| Vaginal bleeding pattern | 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. | Up to 9 months | 
| Dysmenorrhea | Dysmenorrhea will be collacted by a self-developed questionnarie (on a 10-point scale). A higher score indicated higher level of pain. | Up to 9 months | 
| Waist and abdomen pain related to gynecology | The pain will be collacted by a self-developed questionnarie (on a 10-point scale). A higher score indicated higher level of pain. | Up to 9 months | 
| Sexual intercourse pain | The pain will be collacted by a self-developed questionnarie (on a 10-point scale). A higher score indicated higher level of pain. | Up to 9 months |