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

Contraceptive Usage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05362019
• Other study ID #: 2021HX019
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2022
• Est. completion date: March 2023

Study information

• Verified date: May 2022
• Source: National Research Institute for Family Planning, China
• Contact: Denghui Hu
• Phone: +86 13051255513
• Email: hu_dhui[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception Behavior
• Contraceptive Usage

Intervention

Drug:
• Compound Norethisterone Enanthate Injection
Combined injectable contraceptive use

Other:
• One-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.
• Family Planning Service
routine family planning service and contraceptive service.

Locations

Country	Name	City	State
China	Tianjin Central Hospital of Gynecology Obstetrics	Tianjin	Tianjin
China	Tianjin Dongli hospital	Tianjin	Tianjin
China	Tianjin Jinnan hospital	Tianjin	Tianjin
China	Tianjin Medical University second hospital	Tianjin	Tianjin
China	Qinghai People's Hospital	Xining	Qinghai
China	Qinghai Red Cross Hospital	Xining	Qinghai
China	Yunnan Xishuangbanna maternal and Child Health Hospital	Xishuangbanna	Yunnan
China	Yunnan Xishuangbanna people's Hospital	Xishuangbanna	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
National Research Institute for Family Planning, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Termination rate	The termination rates of the two groups were observed for 6 months.	6 months
Primary	Continuation rate	The continuation rates of the two groups were observed for 6 months.	6 months
Primary	Satisfaction rates	The satisfaction rates of two groups after a 6 months of contraceptive use.	Up to 4 weeks
Secondary	Complaint of adverse reactions	Complaint rates of various adverse reactions (dizziness / breast swelling / nausea) during different follow-up time.	Up to 9 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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