ContraceptionNCT05383924
Intrauterine Contraceptive Device Insertion During Cesarean Section (CS) Versus Delayed Insertion
A study testing postplacental IUD insertion and delayed IUD insertion in people with Contraception and IUD, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
After ethical committee approval and written consent from the patients, this prospective quasi-randomized controlled clinical trial was performed on pregnant women planning to deliver by cesarean section and willing to participate in the study to investigate the value of immediate post placental IUD insertion versus… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Contraception, IUD
- What is being tested?
- postplacental IUD insertion and delayed IUD insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 5 Jun 2022
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women planned for delivery by cesarean section in Ain Shams University Maternity hospital
Who cannot join
- Women not consenting to use IUD as a contraceptive method and preferring other methods.
- Any woman with condition included in Category 3 or 4 for Cu-IUD in medical eligibility criteria for contraceptive use World Health Organization (WHO) 2015
- Neuropsychiatric disorder causing altered mentality or perception
- Intrapartum complications as chorioamnionitis, massive blood loss, or hysterectomy.
- Anemic patients (hemoglobin level <10g/dl).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient's Compliance to Intrauterine Device: Immediate Postplacental Insertion Versus Delayed Insertion in Women Undergoing Planned Cesarean Section
After ethical committee approval and written consent from the patients, this prospective quasi-randomized controlled clinical trial was performed on pregnant women planning to deliver by cesarean section and willing to participate in the study to investigate the value of immediate post placental IUD insertion versus delayed insertion on patient's compliance in Ain Shams University Maternity Hospital (ASUMH).
Read the detailed description
- After protocol approval by the ethical committee of the department of Obstetrics \& Gynecology, Faculty of Medicine, Ain Shams University; pregnant woman planning to undergo elective cesarean section in ASUMH were recruited from the antenatal clinic.
- Counselling was done about different postpartum contraceptive methods including immediate PPIUD and delayed IUD insertion.
- An informed written consent was taken from all participants before enrollment in the study and after explaining the purpose, possible risks and complications.
- History taking, examination, and investigations (CBC, follow-up Ultrasound) were done to identify eligible patients according to the inclusion and exclusion criteria.
- Randomization: Eligible patients were quasi-randomized into 2 groups:
Group (A) (PPIUD group): immediate postplacental IUD insertion. Group (B) (delayed insertion group): delayed IUD insertion at the 6th week postpartum visit.
Randomization was done through "Alternation" method.
- Allocation: the first patient (no.1) was allocated to group (A) and second patient (no.2) to group (B) and so on by ''Alternation method '' till fulfilling the sample size.
Procedure:
Type of IUD: Model T-shaped Copper 380 A: Safe-load® or Pregna®
- Group A (PPIUD group): cesarean section (CS) was performed by experts in post-placental IUD insertion as follows: The IUD was inserted after removal of the placenta and after the uterus had become hemostatic. After initiating closure of the uterine incision, the IUD was placed at the top of uterine fundus manually. Before closing the uterine incision, the strings were placed gently in the lower uterine segment manually. After this was accomplished, the uterine incision closure could be completed. The strings usually descended spontaneously through the cervix during the puerperal period. If the cervix was closed, it would be dilated from above with ring forceps. Strings can be passed through the cervix with ring forceps. If this was done, the surgeon would recheck to make sure IUD remains at the fundus of the uterus prior to closing the uterine incision. Strings can be trimmed at a follow-up visit. Ultrasound was done after the CS to ensure proper placement of the IUD.
- Group B (control group) (delayed insertion group): cesarean section was done by expert supervisors, then contacts were taken to arrange for delayed IUD Insertion at the 6th week postpartum visit as follows: IUD was prepared prior to starting procedure. Vaginal speculum was placed then prepared vaginal wall with betadine. Tenaculum was applied at anterior cervical position then uterine sounding was performed. IUD was placed according to package insert, then the threads were cut 2-3 cm from cervical os. Ultrasound was done to ensure proper placement of the IUD.
- Follow-up: follow-up visits were conducted at 6, 12months post-insertion (questionnaire, ultrasound, hemoglobin level).
- Conditions
- Contraception, IUD
- Being tested
- postplacental IUD insertion, delayed IUD insertion
- Keywords
- IUD, immediate postplacental IUD, interval IUD insertion, compliance, expulsion
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postplacental IUD insertionProcedure or surgery
Also called immediate postplacental IUD insertion
patients will have immediate postplacental IUD insertion as follows: The IUD is inserted after removal of the placenta and after the uterus has become hemostatic. After initiating closure of the uterine incision, the IUD is placed at the top of uterine fundus manually. Before closing the uterine incision, the strings are placed gently in the lower uterine segment manually. After this is accomplished, the uterine incision closure can be completed. The strings will usually descend spontaneously through the cervix during the puerperal period. If the cervix is closed, it'll be dilated from above with ring forceps. Strings can be passed through the cervix with ring forceps. If this is done, the surgeon will recheck to make sure IUD remains at the fundus of the uterus prior to closing the uterine incision. Strings can be trimmed at a follow-up visit.
Ultrasound will be done after the CS to ensure proper placement of the IUD.
delayed IUD insertionProcedure or surgery
Also called interval IUD insertion
cesarean section will be done, then contacts will be taken to arrange for delayed IUD insertion at the 6th week postpartum visit as follows: Prepare IUD prior to starting procedure Place vaginal speculum then prepare vaginal wall with betadine Apply tenaculum at anterior cervical position then insert and remove uterine sound Place IUD according to package insert then cut threads 2-3 cm from cervical os. Ultrasound will be done to ensure proper placement of the IUD.
| Study group | Role | What they receive |
|---|---|---|
| postplacental IUD (PP-IUD) insertion | Active comparator | patients will have immediate postplacental IUD insertion Receives: Procedure: postplacental IUD insertion |
| delayed IUD insertion | Active comparator | cesarean section will be done, then contacts will be taken to arrange for delayed IUD insertion at the 6th week postpartum visit Receives: Procedure: delayed IUD insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient compliance
compliance to IUD will be assessed by a user satisfaction questionnaire with scoring system: Q1, on a scale from 0 to 10, Are You satisfied of using Cu-IUD as a contraceptive method? (When 0 means "Not at all satisfied" and 10 means "Extremely Satisfied") 0 1 2 3 4 5 6 7 8 9 10 Q2, Will you continue to use Cu-IUD in future or reuse it after discontinuation? 1 = Yes 0 = No Q3, Do you recommend Cu-IUD for others to use it as a contraceptive method?
1 = Yes 0 = No
Measured: at 6 months after the procedure
Patient compliance
compliance to IUD will be assessed by a user satisfaction questionnaire with scoring system: Q1, on a scale from 0 to 10, Are You satisfied of using Cu-IUD as a contraceptive method? (When 0 means "Not at all satisfied" and 10 means "Extremely Satisfied") 0 1 2 3 4 5 6 7 8 9 10 Q2, Will you continue to use Cu-IUD in future or reuse it after discontinuation? 1 = Yes 0 = No Q3, Do you recommend Cu-IUD for others to use it as a contraceptive method?
1 = Yes 0 = No
Measured: at 12 months after the procedure
Secondary outcomes (5)
Abnormal Bleeding pattern
heavy menstrual bleeding or other abnormal uterine bleeding as reported by history taking
Measured: at 12 months after the procedure
dyspareunia
pain during intercourse, as reported by history taking
Measured: at 12months after the procedure
Efficiency
successful insertion and proper position of the IUD, as confirmed by ultrasound imaging
Measured: at 6 months after the procedure
Efficiency
proper position of the IUD, as confirmed by ultrasound imaging
Measured: at 12 months after the procedure
Anemia
hemoglobin drop by follow-up of hemoglobin level after the procedure
Measured: at 12months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start1 May 2021
- Primary completion1 May 2022
- Study completion5 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study aims to compare immediate postplacental IUD insertion versus delayed insertion as regards patient's compliance in women undergoing planned cesarean section. One group will have the IUD inserted during cesarean section. Another group will undergo IUD insertion after 6 weeks of delivery by CS.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Hassan Mostafa, Ain Shams Maternity Hospital
- Investigators
- Mohamed Sweed, MD, Study chair, Faculty of Medicine Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383924
- Sponsor's protocol ID
- FMASU MS720/2021
- Status last verified
- Jun 2022
- First submitted
- 14 May 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon reasonable request to the principal investigator, individual participant data can be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient's Compliance to Intrauterine Device: Immediate Postplacental Insertion Versus Delayed Insertion in Women Undergoing Planned Cesarean Section
- ClinicalTrials.gov ID
- NCT05383924
- Acronym / sponsor ID
- FMASU MS720/2021
- Conditions
- Contraception, IUD
- Keywords
- IUD, immediate postplacental IUD, interval IUD insertion, compliance, expulsion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 5 Jun 2022 (actual)
- First posted
- 20 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.
After ethical committee approval and written consent from the patients, this prospective quasi-randomized controlled clinical trial was performed on pregnant women planning to deliver by cesarean section and willing to participate in the study to investigate the value of immediate post placental IUD insertion versus delayed insertion on patient's compliance in Ain Shams University Maternity Hospital (ASUMH).
Detailed description
- After protocol approval by the ethical committee of the department of Obstetrics \& Gynecology, Faculty of Medicine, Ain Shams University; pregnant woman planning to undergo elective cesarean section in ASUMH were recruited from the antenatal clinic.
- Counselling was done about different postpartum contraceptive methods including immediate PPIUD and delayed IUD insertion.
- An informed written consent was taken from all participants before enrollment in the study and after explaining the purpose, possible risks and complications.
- History taking, examination, and investigations (CBC, follow-up Ultrasound) were done to identify eligible patients according to the inclusion and exclusion criteria.
- Randomization: Eligible patients were quasi-randomized into 2 groups:
Group (A) (PPIUD group): immediate postplacental IUD insertion. Group (B) (delayed insertion group): delayed IUD insertion at the 6th week postpartum visit.
Randomization was done through "Alternation" method.
- Allocation: the first patient (no.1) was allocated to group (A) and second patient (no.2) to group (B) and so on by ''Alternation method '' till fulfilling the sample size.
Procedure:
Type of IUD: Model T-shaped Copper 380 A: Safe-load® or Pregna®
- Group A (PPIUD group): cesarean section (CS) was performed by experts in post-placental IUD insertion as follows: The IUD was inserted after removal of the placenta and after the uterus had become hemostatic. After initiating closure of the uterine incision, the IUD was placed at the top of uterine fundus manually. Before closing the uterine incision, the strings were placed gently in the lower uterine segment manually. After this was accomplished, the uterine incision closure could be completed. The strings usually descended spontaneously through the cervix during the puerperal period. If the cervix was closed, it would be dilated from above with ring forceps. Strings can be passed through the cervix with ring forceps. If this was done, the surgeon would recheck to make sure IUD remains at the fundus of the uterus prior to closing the uterine incision. Strings can be trimmed at a follow-up visit. Ultrasound was done after the CS to ensure proper placement of the IUD.
- Group B (control group) (delayed insertion group): cesarean section was done by expert supervisors, then contacts were taken to arrange for delayed IUD Insertion at the 6th week postpartum visit as follows: IUD was prepared prior to starting procedure. Vaginal speculum was placed then prepared vaginal wall with betadine. Tenaculum was applied at anterior cervical position then uterine sounding was performed. IUD was placed according to package insert, then the threads were cut 2-3 cm from cervical os. Ultrasound was done to ensure proper placement of the IUD.
- Follow-up: follow-up visits were conducted at 6, 12months post-insertion (questionnaire, ultrasound, hemoglobin level).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study aims to compare immediate postplacental IUD insertion versus delayed insertion as regards patient's compliance in women undergoing planned cesarean section. One group will have the IUD inserted during cesarean section. Another group will undergo IUD insertion after 6 weeks of delivery by CS.
| Arm | Type | Receives |
|---|---|---|
| postplacental IUD (PP-IUD) insertion | Active comparator | Procedure: postplacental IUD insertionpatients will have immediate postplacental IUD insertion |
| delayed IUD insertion | Active comparator | Procedure: delayed IUD insertioncesarean section will be done, then contacts will be taken to arrange for delayed IUD insertion at the 6th week postpartum visit |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women planned for delivery by cesarean section in Ain Shams University Maternity hospital
Key exclusion criteria (5 listed)
- Women not consenting to use IUD as a contraceptive method and preferring other methods.
- Any woman with condition included in Category 3 or 4 for Cu-IUD in medical eligibility criteria for contraceptive use World Health Organization (WHO) 2015
- Neuropsychiatric disorder causing altered mentality or perception
- Intrapartum complications as chorioamnionitis, massive blood loss, or hysterectomy.
- Anemic patients (hemoglobin level <10g/dl).
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 |
|---|---|---|
| postplacental IUD insertionAlso: immediate postplacental IUD insertionpatients will have immediate postplacental IUD insertion as follows: The IUD is inserted after removal of the placenta and after the uterus has become hemostatic. After initiating closure of the uterine incision, the IUD is placed at the top of uterine fundus manually. Before closing the uterine incision, the strings are placed gently in the lower uterine segment manually. After this is accomplished, the uterine incision closure can be completed. The strings will usually descend spontaneously through the cervix during the puerperal period. If the cervix is closed, it'll be dilated from above with ring forceps. Strings can be passed through the cervix with ring forceps. If this is done, the surgeon will recheck to make sure IUD remains at the fundus of the uterus prior to closing the uterine incision. Strings can be trimmed at a follow-up visit. Ultrasound will be done after the CS to ensure proper placement of the IUD. | Procedure or surgery | postplacental IUD (PP-IUD) insertion |
| delayed IUD insertionAlso: interval IUD insertioncesarean section will be done, then contacts will be taken to arrange for delayed IUD insertion at the 6th week postpartum visit as follows: Prepare IUD prior to starting procedure Place vaginal speculum then prepare vaginal wall with betadine Apply tenaculum at anterior cervical position then insert and remove uterine sound Place IUD according to package insert then cut threads 2-3 cm from cervical os. Ultrasound will be done to ensure proper placement of the IUD. | Procedure or surgery | delayed IUD insertion |
Primary outcome
Patient compliance
Time frame: at 6 months after the procedure
compliance to IUD will be assessed by a user satisfaction questionnaire with scoring system: Q1, on a scale from 0 to 10, Are You satisfied of using Cu-IUD as a contraceptive method? (When 0 means "Not at all satisfied" and 10 means "Extremely Satisfied") 0 1 2 3 4 5 6 7 8 9 10 Q2, Will you continue to use Cu-IUD in future or reuse it after discontinuation? 1 = Yes 0 = No Q3, Do you recommend Cu-IUD for others to use it as a contraceptive method? 1 = Yes 0 = No
Patient compliance
Time frame: at 12 months after the procedure
compliance to IUD will be assessed by a user satisfaction questionnaire with scoring system: Q1, on a scale from 0 to 10, Are You satisfied of using Cu-IUD as a contraceptive method? (When 0 means "Not at all satisfied" and 10 means "Extremely Satisfied") 0 1 2 3 4 5 6 7 8 9 10 Q2, Will you continue to use Cu-IUD in future or reuse it after discontinuation? 1 = Yes 0 = No Q3, Do you recommend Cu-IUD for others to use it as a contraceptive method? 1 = Yes 0 = No
5 secondary outcomes
Abnormal Bleeding pattern
Time frame: at 12 months after the procedure
dyspareunia
Time frame: at 12months after the procedure
Efficiency
Time frame: at 6 months after the procedure
Efficiency
Time frame: at 12 months after the procedure
Anemia
Time frame: at 12months after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: Yes. upon reasonable request to the principal investigator, individual participant data can be shared
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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.
Mohamed Sweed, MD study chair
Faculty of Medicine Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postplacental IUD insertion and delayed IUD insertion in people with Contraception and IUD, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient compliance (time frame: at 6 months after the procedure). The study lists 2 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 23 Jun 2022.