NCT05362019

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

April 22, 2022

Last Update Submit

May 1, 2022

Conditions

Contraception BehaviorContraceptive Usage

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Complaint of adverse reactions

    Up to 9 months

  • Vaginal bleeding pattern

    Up to 9 months

  • Dysmenorrhea

    Up to 9 months

  • Waist and abdomen pain related to gynecology

    Up to 9 months

  • Sexual intercourse pain

    Up to 9 months

Study Arms (2)

intervention group

EXPERIMENTAL

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 InjectionOther: One-to-one Service

control group

ACTIVE COMPARATOR

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

Drug: Compound Norethisterone Enanthate InjectionOther: Family Planning Service

Interventions

Compound Norethisterone Enanthate InjectionDRUG

Combined injectable contraceptive use

control groupintervention group
One-to-one ServiceOTHER

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

intervention group
Family Planning ServiceOTHER

routine family planning service and contraceptive service.

control group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Qinghai People's Hospital

Xining, Qinghai, China

Location

Qinghai Red Cross Hospital

Xining, Qinghai, China

Location

Tianjin Central Hospital of Gynecology Obstetrics

Tianjin, Tianjin Municipality, China

Location

Tianjin Dongli hospital

Tianjin, Tianjin Municipality, China

Location

Tianjin Jinnan hospital

Tianjin, Tianjin Municipality, China

Location

Tianjin Medical University second hospital

Tianjin, Tianjin Municipality, China

Location

Yunnan Xishuangbanna maternal and Child Health Hospital

Xishuangbanna Dai Autonomous Prefecture, Yunnan, China

Location

Yunnan Xishuangbanna people's Hospital

Xishuangbanna Dai Autonomous Prefecture, Yunnan, China

Location

MeSH Terms

Conditions

Contraception Behavior

Interventions

Family Planning Services

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Community Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesReproductive Health Services

Study Officials

  • Kaiyan Pei

    National Research Institute for Family Planning, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denghui Hu

CONTACT

+86 13051255513hu_dhui@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2022

First Posted

May 5, 2022

Study Start

May 1, 2022

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

May 5, 2022

Record last verified: 2022-05

Locations

CN(8)