Contraception BehaviorNCT05362019
Effects of One-to-one Service on the Continuation and Satisfaction of Contraceptive Use.
A study testing Compound Norethisterone Enanthate Injection, One-to-one Service and Family Planning Service in people with Contraception Behavior and Contraceptive Usage, run by National Research Institute for Family Planning, China at 8 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception Behavior, Contraceptive Usage
- What is being tested?
- Compound Norethisterone Enanthate Injection, One-to-one Service and Family Planning Service
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 8 sitesChina
- Study dates
- May 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, Tianjin Municipality
Hua Yang
Tianjin Dongli hospital
Tianjin, Tianjin Municipality
Yan Wang
Tianjin Jinnan hospital
Tianjin, Tianjin Municipality
Shaoxia Liu
Tianjin Medical University second hospital
Tianjin, Tianjin Municipality
Jianmei Wang
Qinghai People's Hospital
Xining, Qinghai
Donyue Wu
Qinghai Red Cross Hospital
Xining, Qinghai
Ying Lou
Yunnan Xishuangbanna maternal and Child Health Hospital
Xishuangbanna Dai Autonomous Prefecture, Yunnan
Meixiu Tan
Yunnan Xishuangbanna people's Hospital
Xishuangbanna Dai Autonomous Prefecture, Yunnan
Juan Peng
About this study
Official title: Effects of One-to-one Service on the Continuation and Satisfaction of Combined Injectable Contraceptive Use.
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.
Read the 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.
- Conditions
- Contraception Behavior, Contraceptive Usage
- Being tested
- Compound Norethisterone Enanthate Injection, One-to-one Service, Family Planning Service
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Norethisterone Enanthate InjectionDrug
Combined injectable contraceptive use
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.
Family Planning ServiceOther
routine family planning service and contraceptive service.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Compound Norethisterone Enanthate Injection; Other: One-to-one Service |
| control group | Active comparator | Routine family planning services will be provided to the control group. Receives: Drug: Compound Norethisterone Enanthate Injection; Other: Family Planning Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Termination rate
The termination rates of the two groups were observed for 6 months.
Measured: 6 months
Continuation rate
The continuation rates of the two groups were observed for 6 months.
Measured: 6 months
Satisfaction rates
The satisfaction rates of two groups after a 6 months of contraceptive use.
Measured: Up to 4 weeks
Secondary outcomes (5)
Complaint of adverse reactions
Complaint rates of various adverse reactions (dizziness / breast swelling / nausea) during different follow-up time.
Measured: Up to 9 months
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.
Measured: Up to 9 months
Dysmenorrhea
Dysmenorrhea will be collacted by a self-developed questionnarie (on a 10-point scale). A higher score indicated higher level of pain.
Measured: Up to 9 months
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.
Measured: Up to 9 months
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.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study startMay 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraception BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Institute for Family Planning, China
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kaiyan Pei, Principal investigator, National Research Institute for Family Planning, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362019
- Sponsor's protocol ID
- 2021HX019
- Status last verified
- May 2022
- First submitted
- 22 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of One-to-one Service on the Continuation and Satisfaction of Combined Injectable Contraceptive Use.
- ClinicalTrials.gov ID
- NCT05362019
- Acronym / sponsor ID
- 2021HX019
- Conditions
- Contraception Behavior, Contraceptive Usage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Research Institute for Family Planning, ChinaOther government
- Study start
- May 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Compound Norethisterone Enanthate Injection, Other: One-to-one ServiceA mobile phone based "service system" developed by the research group will be used to provide one-to-one service for the intervention group. |
| control group | Active comparator | Drug: Compound Norethisterone Enanthate Injection, Other: Family Planning ServiceRoutine family planning services will be provided to the control group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 18 to 40 years old;
- Healthy Volunteers;
- More than 6 months after delivery and without lactation;
- No fertility intention within 6 months;
- Normal menstruation;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound Norethisterone Enanthate InjectionCombined injectable contraceptive use | Drug | control group, intervention group |
| One-to-one ServiceA mobile phone based "service system" will be used to pushing contraceptive knowledges, reminding injection, providing consultation on adverse reactions and ect. | Other | intervention group |
| Family Planning Serviceroutine family planning service and contraceptive service. | Other | control group |
Primary outcome
Termination rate
Time frame: 6 months
The termination rates of the two groups were observed for 6 months.
Continuation rate
Time frame: 6 months
The continuation rates of the two groups were observed for 6 months.
Satisfaction rates
Time frame: Up to 4 weeks
The satisfaction rates of two groups after a 6 months of contraceptive use.
5 secondary outcomes
Complaint of adverse reactions
Time frame: Up to 9 months
Vaginal bleeding pattern
Time frame: Up to 9 months
Dysmenorrhea
Time frame: Up to 9 months
Waist and abdomen pain related to gynecology
Time frame: Up to 9 months
Sexual intercourse pain
Time frame: Up to 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaiyan Pei principal investigator
National Research Institute for Family Planning, China
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compound Norethisterone Enanthate Injection, One-to-one Service and Family Planning Service in people with Contraception Behavior and Contraceptive Usage, run by National Research Institute for Family Planning, China at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denghui Hu (+86 13051255513, hu_dhui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Termination rate (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.