Mechanical Complication of Intrauterine DevicePhase 1NCT03404622

Immediate Post-placental Insertion of IUCD During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion

A Phase 1 study testing IUCD in people with Mechanical Complication of Intrauterine Device, run by ALshaimaa Aboalhassan Ali at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of current study is to compare the rates of IUCD expulsion and complications in immediate post-placental insertion versus delayed IUCD insertion (6-weeks after cesarean delivery) Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Mechanical Complication of Intrauterine Device
What is being tested?: IUCD
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteEgypt
Study dates: 20 Sep 2016to 20 Dec 2017
Phase: Phase 1
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 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Age: 18 -45
Singleton pregnancy at ≥32 weeks gestation at time of enrollment
Voluntarily requesting to IUD placement for postpartum contraception
Able to give consent and agree to the terms of the study

Who cannot join

Uterine anomaly that preventing replacement of IUD.
Chorioamnionitis (such as prolonged rupture of membranes >18 hours, prolonged labor >24 hours, fever >38C).
Puerperal sepsis and unresolved postpartum hemorrhage.
IUD allergy (copper).
Systemic lupus erythematosus with severe thrombocytopenia

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Ain Shams Maternity Hospital
Cairo, 11311

Other trials in Egypt

About this study

Official title: : Immediate Post-placental Insertion of the Intrauterine Contraceptive Device During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion

The aim of current study is to compare the rates of IUCD expulsion and complications in immediate post-placental insertion versus delayed IUCD insertion (6-weeks after cesarean delivery)

Read the detailed description

Intrauterine devices (IUDs) are among the most effective forms of contraception, offering greater than 99% efficacy per year of use and are completely reversible .

Post-placental intrauterine device (IUD) insertion is a safe, convenient, and effective option for postpartum contraception. "Post-placental" refers to insertion within 10-15 minutes of placental delivery, after vaginal or cesarean delivery.

Conditions: Mechanical Complication of Intrauterine Device
Being tested: IUCD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IUCDDrug
IUCD will be inserted in 100 women post placental removal and will be inserted in anther 100 women after six weeks post cesarean delivery

Study groups in NCT03404622
Study group	Role	What they receive
Postplacental IUCD Insertion during Cesarean section	Active comparator	IUCD inserted postplacental removal Receives: Drug: IUCD
6 Week Post-Cesarean Insertion of IUCD	Active comparator	IUCD inserted after six weeks post Cesarean section delivery Receives: Drug: IUCD

What is being measured

The primary outcome is the main question the study is designed to answer.

Expulsion
The time until expulsion of the IUD will be defined as the time from insertion until expulsion occurred, if known. If the date of expulsion is not known, this will be documented as the day after the IUD was last known to be in place. If a pregnancy is detected and the IUD is absent (and the participant was unaware of expulsion), the expulsion will be assumed to have occurred at the time of conception, as determined by gestational age on ultrasound. Expulsions will be measured as total expulsions and separately noted whether complete or partial
Measured: 3 months

Secondary outcomes (4)

Displacement
The displacement is diagnosed by doing trans-vaginal ultrasound that showed IUCD that displaced up or down word
Measured: 3 months
Infection
The diagnosis of PID will be made based on the 2006 CDC guidelines and the criteria used in the PEACH study.
Measured: 3 months
Bleeding
Irregular bleeding (including spotting, light bleeding, heavy or longer menstrual period) are common in the first 3 months and may persist.
Measured: 3 months
Perforation
The diagnosis of a perforation may be made by a transvaginal sonogram that shows no IUD within the uterus and an abdominal radiograph that show IUD within the abdominal cavity.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 201620 Dec 2017

First posted19 Jan 2018
Study start20 Sep 2016
Primary completion20 Dec 2016
Study completion20 Dec 2017

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 Mechanical Complication of Intrauterine DeviceStudies 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 1
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: 200 pregnant women will be included in this study, will be divided into two groups Group 1 IUCD will be inserted immediate post-placental removal and include 100 pregnant women Group2 IUCD will be inserted 6 weeks postpartum and include 100 pregnant women.
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03404622
Sponsor's protocol ID: shom
Status last verified: Jan 2018
First submitted: 10 Jan 2018
Last updated: 29 Jan 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: : Immediate Post-placental Insertion of the Intrauterine Contraceptive Device During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion
ClinicalTrials.gov ID: NCT03404622
Acronym / sponsor ID: shom
Conditions: Mechanical Complication of Intrauterine Device
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: ALshaimaa Aboalhassan AliUniversity, hospital or other
Study start: 20 Sep 2016 (actual)
Primary completion: 20 Dec 2016 (actual)
Study completion: 20 Dec 2017 (actual)
First posted: 19 Jan 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.

The aim of current study is to compare the rates of IUCD expulsion and complications in immediate post-placental insertion versus delayed IUCD insertion (6-weeks after cesarean delivery)

Detailed description

Intrauterine devices (IUDs) are among the most effective forms of contraception, offering greater than 99% efficacy per year of use and are completely reversible .

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2
Model description: 200 pregnant women will be included in this study, will be divided into two groups Group 1 IUCD will be inserted immediate post-placental removal and include 100 pregnant women Group2 IUCD will be inserted 6 weeks postpartum and include 100 pregnant women.

Arm	Type	Receives
Postplacental IUCD Insertion during Cesarean section	Active comparator	Drug: IUCDIUCD inserted postplacental removal
6 Week Post-Cesarean Insertion of IUCD	Active comparator	Drug: IUCDIUCD inserted after six weeks post Cesarean section delivery

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age: 18 -45
Singleton pregnancy at ≥32 weeks gestation at time of enrollment
Voluntarily requesting to IUD placement for postpartum contraception
Able to give consent and agree to the terms of the study

Key exclusion criteria (5 listed)

Uterine anomaly that preventing replacement of IUD.
Chorioamnionitis (such as prolonged rupture of membranes >18 hours, prolonged labor >24 hours, fever >38C).
Puerperal sepsis and unresolved postpartum hemorrhage.
IUD allergy (copper).
Systemic lupus erythematosus with severe thrombocytopenia

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
IUCDIUCD will be inserted in 100 women post placental removal and will be inserted in anther 100 women after six weeks post cesarean delivery	Drug	6 Week Post-Cesarean Insertion of IUCD, Postplacental IUCD Insertion during Cesarean section

Primary outcome

Expulsion
Time frame: 3 months
The time until expulsion of the IUD will be defined as the time from insertion until expulsion occurred, if known. If the date of expulsion is not known, this will be documented as the day after the IUD was last known to be in place. If a pregnancy is detected and the IUD is absent (and the participant was unaware of expulsion), the expulsion will be assumed to have occurred at the time of conception, as determined by gestational age on ultrasound. Expulsions will be measured as total expulsions and separately noted whether complete or partial

4 secondary outcomes

Displacement
Time frame: 3 months
Infection
Time frame: 3 months
Bleeding
Time frame: 3 months
Perforation
Time frame: 3 months

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 29 Jan 2018.
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.
Individual participant dataSharing planned: No

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.

Yasser M Aboutalib, MD study director

Ain Shams University

Ahmed S AbdelHamid, MD study director

Ain Shams University

ALshaimaa A Ali, MBBch principal investigator

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 Phase 1 study testing IUCD in people with Mechanical Complication of Intrauterine Device, run by ALshaimaa Aboalhassan Ali 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 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 29 Jan 2018. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Expulsion (time frame: 3 months). 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 NCT03404622, 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 29 Jan 2018.