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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Contraception Behavior; Contraceptive Usage
• Intervention / Treatment: Drug: Compound Norethisterone Enanthate Injection; Other: One-to-one Service; Other: Family Planning Service

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Denghui Hu; Phone Number: +86 13051255513; Email: hu_dhui@163.com

Study Locations

• China
  • Qinghai
    • Xining, Qinghai, China
      • Qinghai People's Hospital
      • Contact: Donyue Wu
    • Xining, Qinghai, China
      • Qinghai Red Cross Hospital
      • Contact: Ying Lou
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Central Hospital of Gynecology obstetrics
      • Contact: Hua Yang
    • Tianjin, Tianjin, China
      • Tianjin Dongli hospital
      • Contact: Yan Wang
    • Tianjin, Tianjin, China
      • Tianjin Jinnan hospital
      • Contact: Shaoxia Liu
    • Tianjin, Tianjin, China
      • Tianjin Medical University Second Hospital
      • Contact: Jianmei Wang
  • Yunnan
    • Xishuangbanna, Yunnan, China
      • Yunnan Xishuangbanna maternal and Child Health Hospital
      • Contact: Meixiu Tan
    • Xishuangbanna, Yunnan, China
      • Yunnan Xishuangbanna people's Hospital
      • Contact: Juan Peng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: control group; Routine family planning services will be provided to the control group.	Drug: Compound Norethisterone Enanthate Injection; Combined injectable contraceptive use; Other: Family Planning Service; routine family planning service and contraceptive service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complaint of adverse reactions	Complaint rates of various adverse reactions (dizziness / breast swelling / nausea) during different follow-up time.	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.	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.	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.	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.	Up to 9 months

Collaborators and Investigators

• Sponsor: National Research Institute for Family Planning, China
• Investigators: Principal Investigator: Kaiyan Pei, National Research Institute for Family Planning, China

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: May 1, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 1, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Norethindrone; Norethindrone Acetate; Norethindrone enanthate
• Other Study ID Numbers: 2021HX019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No