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

NCT ID: NCT05362019

Last Updated: 2022-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2023-03-31

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.

Conditions

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Contraception Behavior Contraceptive Usage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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intervention group

A mobile phone based "service system" developed by the research group will be used to provide one-to-one service for the intervention group.

Group Type EXPERIMENTAL

Compound Norethisterone Enanthate Injection

Intervention Type DRUG

Combined injectable contraceptive use

One-to-one Service

Intervention Type OTHER

A mobile phone based "service system" will be used to pushing contraceptive knowledges, reminding injection, providing consultation on adverse reactions and ect.

control group

Routine family planning services will be provided to the control group.

Group Type ACTIVE_COMPARATOR

Compound Norethisterone Enanthate Injection

Intervention Type DRUG

Combined injectable contraceptive use

Family Planning Service

Intervention Type OTHER

routine family planning service and contraceptive service.

Interventions

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Compound Norethisterone Enanthate Injection

Combined injectable contraceptive use

Intervention Type DRUG

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.

Intervention Type OTHER

Family Planning Service

routine family planning service and contraceptive service.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Institute for Family Planning, China

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kaiyan Pei

Role: PRINCIPAL_INVESTIGATOR

National Research Institute for Family Planning, China

Locations

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Qinghai People's Hospital

Xining, Qinghai, China

Site Status

Qinghai Red Cross Hospital

Xining, Qinghai, China

Site Status

Tianjin Central Hospital of Gynecology Obstetrics

Tianjin, Tianjin Municipality, China

Site Status

Tianjin Dongli hospital

Tianjin, Tianjin Municipality, China

Site Status

Tianjin Jinnan hospital

Tianjin, Tianjin Municipality, China

Site Status

Tianjin Medical University second hospital

Tianjin, Tianjin Municipality, China

Site Status

Yunnan Xishuangbanna maternal and Child Health Hospital

Xishuangbanna Dai Autonomous Prefecture, Yunnan, China

Site Status

Yunnan Xishuangbanna people's Hospital

Xishuangbanna Dai Autonomous Prefecture, Yunnan, China

Site Status

Countries

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China

Central Contacts

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Denghui Hu

Role: CONTACT

+86 13051255513

Facility Contacts

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Donyue Wu

Role: primary

Ying Lou

Role: primary

Hua Yang

Role: primary

Yan Wang

Role: primary

Shaoxia Liu

Role: primary

Jianmei Wang

Role: primary

Meixiu Tan

Role: primary

Juan Peng

Role: primary

Other Identifiers

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2021HX019

Identifier Type: -

Identifier Source: org_study_id

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