Contraception Behavior, Contraceptive Usage
Conditions
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.
Interventions
DRUGCompound Norethisterone Enanthate Injection
Combined injectable contraceptive use
OTHEROne-to-one Service
A mobile phone based service system will be used to pushing contraceptive knowledges, reminding injection, providing consultation on adverse reactions and ect.
OTHERFamily Planning Service
routine family planning service and contraceptive service.
Sponsors
National Research Institute for Family Planning, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Complaint of adverse reactions | Up to 9 months | Complaint rates of various adverse reactions (dizziness / breast swelling / nausea) during different follow-up time. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactDenghui Hu
Outcome results
None listed