ContraceptionNCT03492034
IUD Insertion During Cesarean Section
A study testing IUD during CS and IUD after puerperium in people with Contraception, run by Ain Shams University at 1 site in Egypt.
Trial summary
Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical Trial Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- IUD during CS and IUD after puerperium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 20 Dec 2019
- 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 woman aged between 18 to 40 years old.
- Scheduled for elective cesarean section at gestational age between 37 to 42 weeks.
- Body mass index between 19-30 kg/m2
- Seeking contraception after delivery.
Who cannot join
- History of menorrhagia or severe dysmenorrhea.
- History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis).
- Patients who have bleeding disorders.
- Anemia (Hb < 9 g %).
- Chronic depilating diseases reducing immunity such as Diabetes.
- Structural uterine anomaly or large uterine fibroids distorting anatomy.
Show all 13Show fewer
- History of previous IUD expulsion or removal for complications.
- Unexplained uterine bleeding.
- Copper allergy or Wilson disease.
- Gestational trophoblastic disease with persistently elevated Beta HCG.
- Predisposing factor to postoperative infection (e.g. rupture of membranes prior to admission or delivery of a stillborn baby at cesarean section).
- Complications during cesarean section e.g. postpartum hemorrhage.
- Cesarean section during placenta previa.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insertion of Intrauterine Contraceptive Device During Cesarean Section: Randomized Clinical Trial
Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical Trial
- Conditions
- Contraception
- Being tested
- IUD during CS, IUD after puerperium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUD during CSDevice
IUD insertion during CS
IUD after puerperiumDevice
IUD after puerperium
| Study group | Role | What they receive |
|---|---|---|
| IUD during CS | Active comparator | Not described Receives: Device: IUD during CS |
| IUD after puerperium | Active comparator | Not described Receives: Device: IUD after puerperium |
What is being measured
The primary outcome is the main question the study is designed to answer.
IUD expulsion rate
Measured: 6 weeks
Secondary outcomes (4)
Bleeding
number of pads changed per day
Measured: 6 weeks
Degree of Pain
Visual Analogue Scale from 1 to10 (0 being no pain and 10 maximum pain tolerated)
Measured: 6 weeks
dyspareunia
Visual Analogue Scale from 0 to10 (0 being no pain and 10 maximum pain tolerated)
Measured: 6 weeks
patient satisfaction
Visual Analogue Scale from 0 to10 (0 being maximum dis-satisfaction and 10 maximum satisfaction)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 Apr 2018
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492034
- Sponsor's protocol ID
- AS1750
- Status last verified
- May 2020
- First submitted
- 24 Mar 2018
- Last updated
- 27 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3.
PubMed 36302159
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insertion of Intrauterine Contraceptive Device During Cesarean Section: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03492034
- Acronym / sponsor ID
- AS1750
- Conditions
- Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 10 Apr 2018 (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.
Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical Trial
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IUD during CS | Active comparator | Device: IUD during CS |
| IUD after puerperium | Active comparator | Device: IUD after puerperium |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant woman aged between 18 to 40 years old.
- Scheduled for elective cesarean section at gestational age between 37 to 42 weeks.
- Body mass index between 19-30 kg/m2
- Seeking contraception after delivery.
Key exclusion criteria (13 listed)
- History of menorrhagia or severe dysmenorrhea.
- History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis).
- Patients who have bleeding disorders.
- Anemia (Hb < 9 g %).
- Chronic depilating diseases reducing immunity such as Diabetes.
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 |
|---|---|---|
| IUD during CSIUD insertion during CS | Device | IUD during CS |
| IUD after puerperiumIUD after puerperium | Device | IUD after puerperium |
Primary outcome
IUD expulsion rate
Time frame: 6 weeks
4 secondary outcomes
Bleeding
Time frame: 6 weeks
Degree of Pain
Time frame: 6 weeks
dyspareunia
Time frame: 6 weeks
patient satisfaction
Time frame: 6 weeks
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 27 May 2020.
- Derived from this study: PubMed 36302159Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IUD during CS and IUD after puerperium in people with Contraception, run by Ain Shams 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 4 inclusion and 13 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 27 May 2020. 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?
IUD expulsion rate (time frame: 6 weeks). 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 NCT03492034, which also lists 1 linked publication.
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 27 May 2020.