Clinical trial NCT05362019: Effects of One-to-one Service on the Continuation and Satisfaction of Contraceptive Use.
Official title: Effects of One-to-one Service on the Continuation and Satisfaction of Combined Injectable Contraceptive Use.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contraception Behavior
Contraceptive Usage
Lead sponsor: National Research Institute for Family Planning, China
Sponsor class: OTHER_GOV
First posted: 2022-05-05
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Termination rate
timeFrame: 6 months
measure: Continuation rate
timeFrame: 6 months
measure: Satisfaction rates
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Complaint of adverse reactions
timeFrame: Up to 9 months
measure: Vaginal bleeding pattern
timeFrame: Up to 9 months
measure: Dysmenorrhea
timeFrame: Up to 9 months
measure: Waist and abdomen pain related to gynecology
timeFrame: Up to 9 months
measure: Sexual intercourse pain
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Xining
country: China
facility: Qinghai People's Hospital
state: Qinghai
city: Xining
country: China
facility: Qinghai Red Cross Hospital
state: Qinghai
city: Tianjin
country: China
facility: Tianjin Central Hospital of Gynecology Obstetrics
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Dongli hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Jinnan hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University second hospital
state: Tianjin
city: Xishuangbanna
country: China
facility: Yunnan Xishuangbanna maternal and Child Health Hospital
state: Yunnan
city: Xishuangbanna
country: China
facility: Yunnan Xishuangbanna people's Hospital
state: Yunnan
Study officials:
affiliation: National Research Institute for Family Planning, China
name: Kaiyan Pei
role: PRINCIPAL_INVESTIGATOR
References: