Postpartum ContraceptionNCT05756998
New Method of IUD Insertion During Cesarian Section
A study testing Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique), Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique) and cesarian section in people with Postpartum Contraception, run by Cairo University at 1 site in Egypt.
Trial summary
In women undergoing elective CS, half of them will have Intra-caesarian copper T 380 IUD insertion using the standard method and the remaining half will undergo copper T 380 IUD insertion during CS using a new technique in order to detect which technique is more effective in having more accurate IUD position with… 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
- Postpartum Contraception
- What is being tested?
- Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique), Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique) and cesarian section
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2022to 15 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
- pregnant , full term patients , scheduled for elective CS.
Who cannot join
- contraindications for IUD insertion ( chorioamnionitis , congenital uterine malformations ) - Patient refusing IUD contraception.
- Patients with intra-operative bleeding or vital instability.
- Active genital infection at time of insertion.
- Medical disorders e.g. : cardiac , bleeding disorders , T.B. .. etc.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy outpatient infertility clinic
Cairo
bassiony dabian, MD, 1095195513, bassiony.dabian@gmail.com
About this study
In women undergoing elective CS, half of them will have Intra-caesarian copper T 380 IUD insertion using the standard method and the remaining half will undergo copper T 380 IUD insertion during CS using a new technique in order to detect which technique is more effective in having more accurate IUD position with visible threads.
Read the detailed description
Intrauterine device (IUD) is considered one of the most acceptable and effective contraceptive methods used. It is widely accepted and used in Egypt at a large scale than any other type of contraception with many advantages over the other types of contraceptive methods including long acting hormonal methods . Despite IUD complications, it remains the most accepted method, as it has many advantages like being non-coital related, had no systemic complications, of long duration and reversible with rapid return of fertility after its removal . The complications of IUD include heavy menstrual bleedings, menstrual irregularities and infection complications which could be minimized by using strict aseptic techniques during insertion . The most distressing complication is the displacement of IUD, especially if this displacement was extra-uterine, as the patient needs a surgical maneuver (endoscopic usually) for extraction of this IUD. Displacement of IUDs puts a financial and psychological burden to the patient also increases the risk of unwanted pregnancies and its related risks . Displacement of IUD occurs mainly during its insertion, and occurs mainly due to rough or wrong technique; also IUD insertion at a wrong timing may increase risk of IUD displacement. So it is very important to insert IUDs at the proper time with the proper technique . Timing of insertion of IUD after cesarean section is a matter of debate, some gynecologists insert IUDs during cesarean section after placental removal, while other gynecologists prefer insertion of IUDs after an interval either immediately after puerprium (42 days), or after 6 months post-cesarean section, but the majority inserts IUDs after 3 months from cesarean section . The idea of waiting a three-month interval after cesarean section is to assure that the scar had completely healed and the uterus involutes completely to its pre-pregnancy size. The drawbacks of waiting this long interval are poor accessibility of the cervix which may be pulled upward in some cases of repeated cesarean section and loss of self-enthusiasm for rapid contraception after delivery .
- Conditions
- Postpartum Contraception
- Being tested
- Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique), Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique), cesarian section
- Keywords
- IUD, cesarian section, expulsion, postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique)Device
During CS , placement of CuT380 IUD at the top of the uterine fundus with ring forceps or manually; before closing the uterine incision, the strings were placed in the lower uterine segment. If the cervix was closed, dilatation from above with ring forceps or manually. Strings passed through the cervix with ring forceps, then checking that IUD remains at the fundus of the uterus prior to closing the uterine incision. The surgeon took a good care not to include IUD strings within the sutures. Six weeks postpartum; Patients will be questioned for any symptoms of complications or side effects. Pelvic examination (per speculum) and transvaginal ultrasound will be performed. Patient satisfaction will be assessed: pain using (VAS score), missed threads.
Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique)Device
During CS, the plunger will be removed, the introducer remains in place and the arms of the IUD were released to be in a transverse position. The introducer will be inserted in the cervical canal through the uterine incision, threads might be shortened if needed or if couldn't be advanced into the cervical canal, The introducer containing the IUD will be then pushed upwards , towards the uterine fundus.The IUD will be placed at the uterine fundus and the IUD will be stabilized at its fundal position by grasping the fundus between the thumb anteriorly and the other fingers posteriorly. The uterine incision was closed while the introducer is in situ , then the introducer will be removed vaginally at the end of CS. Six weeks postpartum; Patients will be followed as in the classic technique group.
cesarian sectionProcedure or surgery
Under general or spinal anathesia , the abdomen is opened in layers , the bladder is dissected downwards . The uterus is incised at its lower segment \& the fetus is extracted , followed by the placenta \& membranes . The CU T 380 IUD is inserted either by the classic technique or the standard technique . The uterus is closed in 2 layers by continous non - locked sutures .Proper hemostasis \& closure of the abdomen in layers .
| Study group | Role | What they receive |
|---|---|---|
| classic technique | Active comparator | Not described Receives: Device: Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique); Procedure: cesarian section |
| new technique | Experimental | Not described Receives: Device: Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique); Procedure: cesarian section |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of IUD position.
using ultrasound the position of IUD by measuring the distance between the IUD \& the fundus of the uterus.
Measured: 3 months
visibility of the threads of IUD.
using a cusco speculum , the IUD threads are inspected.
Measured: 3 months
Secondary outcomes (2)
complications of IUD
complications as pain , vaginal bleeding , infection are followed using specific questionnaire filled by the patient
Measured: 1 month
patient overall satisfaction about the new technique
using specific questionnaire to be filled by the patient
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start2 Feb 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postpartum ContraceptionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassiony Dabian, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756998
- Sponsor's protocol ID
- MS-673-2021
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cleland J, Ali M, Benova L, Daniele M. The promotion of intrauterine contraception in low- and middle-income countries: a narrative review. Contraception. 2017 Jun;95(6):519-528. doi: 10.1016/j.contraception.2017.03.009. Epub 2017 Mar 30.
PubMed 28365165Goldstuck ND, Steyn PS. Insertion of intrauterine devices after cesarean section: a systematic review update. Int J Womens Health. 2017 Apr 18;9:205-212. doi: 10.2147/IJWH.S132391. eCollection 2017.
PubMed 28458581Sunder, G. and Snigdha, G. (2016) Displaced Intrauterine Device: A Retrospective Study. The Journal of Medical Research, 2, 41-43.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Method of IUD Insertion During Cesarian Section
- ClinicalTrials.gov ID
- NCT05756998
- Acronym / sponsor ID
- MS-673-2021
- Conditions
- Postpartum Contraception
- Keywords
- IUD, cesarian section, expulsion, postpartum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 7 Mar 2023 (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.
In women undergoing elective CS, half of them will have Intra-caesarian copper T 380 IUD insertion using the standard method and the remaining half will undergo copper T 380 IUD insertion during CS using a new technique in order to detect which technique is more effective in having more accurate IUD position with visible threads.
Detailed description
Intrauterine device (IUD) is considered one of the most acceptable and effective contraceptive methods used. It is widely accepted and used in Egypt at a large scale than any other type of contraception with many advantages over the other types of contraceptive methods including long acting hormonal methods . Despite IUD complications, it remains the most accepted method, as it has many advantages like being non-coital related, had no systemic complications, of long duration and reversible with rapid return of fertility after its removal . The complications of IUD include heavy menstrual bleedings, menstrual irregularities and infection complications which could be minimized by using strict aseptic techniques during insertion . The most distressing complication is the displacement of IUD, especially if this displacement was extra-uterine, as the patient needs a surgical maneuver (endoscopic usually) for extraction of this IUD. Displacement of IUDs puts a financial and psychological burden to the patient also increases the risk of unwanted pregnancies and its related risks . Displacement of IUD occurs mainly during its insertion, and occurs mainly due to rough or wrong technique; also IUD insertion at a wrong timing may increase risk of IUD displacement. So it is very important to insert IUDs at the proper time with the proper technique . Timing of insertion of IUD after cesarean section is a matter of debate, some gynecologists insert IUDs during cesarean section after placental removal, while other gynecologists prefer insertion of IUDs after an interval either immediately after puerprium (42 days), or after 6 months post-cesarean section, but the majority inserts IUDs after 3 months from cesarean section . The idea of waiting a three-month interval after cesarean section is to assure that the scar had completely healed and the uterus involutes completely to its pre-pregnancy size. The drawbacks of waiting this long interval are poor accessibility of the cervix which may be pulled upward in some cases of repeated cesarean section and loss of self-enthusiasm for rapid contraception after delivery .
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classic technique | Active comparator | Device: Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique), Procedure: cesarian section |
| new technique | Experimental | Device: Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique), Procedure: cesarian section |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant , full term patients , scheduled for elective CS.
Key exclusion criteria (4 listed)
- contraindications for IUD insertion ( chorioamnionitis , congenital uterine malformations ) - Patient refusing IUD contraception.
- Patients with intra-operative bleeding or vital instability.
- Active genital infection at time of insertion.
- Medical disorders e.g. : cardiac , bleeding disorders , T.B. .. etc.
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 |
|---|---|---|
| Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique)During CS , placement of CuT380 IUD at the top of the uterine fundus with ring forceps or manually; before closing the uterine incision, the strings were placed in the lower uterine segment. If the cervix was closed, dilatation from above with ring forceps or manually. Strings passed through the cervix with ring forceps, then checking that IUD remains at the fundus of the uterus prior to closing the uterine incision. The surgeon took a good care not to include IUD strings within the sutures. Six weeks postpartum; Patients will be questioned for any symptoms of complications or side effects. Pelvic examination (per speculum) and transvaginal ultrasound will be performed. Patient satisfaction will be assessed: pain using (VAS score), missed threads. | Device | classic technique |
| Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique)During CS, the plunger will be removed, the introducer remains in place and the arms of the IUD were released to be in a transverse position. The introducer will be inserted in the cervical canal through the uterine incision, threads might be shortened if needed or if couldn't be advanced into the cervical canal, The introducer containing the IUD will be then pushed upwards , towards the uterine fundus.The IUD will be placed at the uterine fundus and the IUD will be stabilized at its fundal position by grasping the fundus between the thumb anteriorly and the other fingers posteriorly. The uterine incision was closed while the introducer is in situ , then the introducer will be removed vaginally at the end of CS. Six weeks postpartum; Patients will be followed as in the classic technique group. | Device | new technique |
| cesarian sectionUnder general or spinal anathesia , the abdomen is opened in layers , the bladder is dissected downwards . The uterus is incised at its lower segment \& the fetus is extracted , followed by the placenta \& membranes . The CU T 380 IUD is inserted either by the classic technique or the standard technique . The uterus is closed in 2 layers by continous non - locked sutures .Proper hemostasis \& closure of the abdomen in layers . | Procedure or surgery | classic technique, new technique |
Primary outcome
accuracy of IUD position.
Time frame: 3 months
using ultrasound the position of IUD by measuring the distance between the IUD \& the fundus of the uterus.
visibility of the threads of IUD.
Time frame: 3 months
using a cusco speculum , the IUD threads are inspected.
2 secondary outcomes
complications of IUD
Time frame: 1 month
patient overall satisfaction about the new technique
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 28365165Cleland J, Ali M, Benova L, Daniele M. The promotion of intrauterine contraception in low- and middle-income countries: a narrative review. Contraception. 2017 Jun;95(6):519-528. doi: 10.1016/j.contraception.2017.03.009. Epub 2017 Mar 30.
- Background: PubMed 28458581Goldstuck ND, Steyn PS. Insertion of intrauterine devices after cesarean section: a systematic review update. Int J Womens Health. 2017 Apr 18;9:205-212. doi: 10.2147/IJWH.S132391. eCollection 2017.
- BackgroundSunder, G. and Snigdha, G. (2016) Displaced Intrauterine Device: A Retrospective Study. The Journal of Medical Research, 2, 41-43.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique), Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique) and cesarian section in people with Postpartum Contraception, run by Cairo University 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 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 7 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact bassiony dabian, MD (1095195513, bassiony.dabian@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of IUD position. (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT05756998, which also lists 3 linked publications.
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 7 Mar 2023.