Contraception BehaviorNCT04136613
Utility of Immediate Post Placental Insertion of Intrauterine Device During Cesarean Delivery
A study testing Copper Intra uterine contarceptive device ( Cu-T 380A) in people with Contraception Behavior, run by Taghreed Alhaidari at 1 site in Iraq.
Trial summary
Iraq is a country that ranks 33rd around world population growth rate. Meanwhile it is one of the counties in the middle east with the highest fertility rate, In addition to the considerable number of unintended pregnancy mainly in postpartum period. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Contraception Behavior
- What is being tested?
- Copper Intra uterine contarceptive device ( Cu-T 380A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2015to 1 Jun 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who delivered by caesarean section whether elective or emergency, counseled for IUD insertion in pre- natal period or at the time of labour and who has the will and her husband to be engaged in the study.
Who cannot join
- Women with positive test for STIs (e.g. gonorrhea or chlamydia) in this pregnancy.
- Uterine anomaly that was known to distort the uterine cavity; whether uterine fibroid or congenital uterine anomalies.
- Developed postpartum hemorrhage.
- Diagnosed chorioamnionitis, intrapartum fever, or ruptured membranes for greater than 24 hours prior to delivery.
- Placenta previa or accrete.
- Anemia during pregnancy (Hb < 10 g/dl).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Post Placental Insertion of Intrauterine Device at Cesarean Delivery, is Acceptable, Feasible and Safe in Iraqi Women.
Iraq is a country that ranks 33rd around world population growth rate. Meanwhile it is one of the counties in the middle east with the highest fertility rate, In addition to the considerable number of unintended pregnancy mainly in postpartum period.
The less use of family planning methods, the higher the fertility rate and the less interpregnancy interval which will carry an obvious more risk to the mother and the fetus especially if the cesarean delivery rate shown an increase trend as the case in Iraq. For that reason, contraception needs to be practiced in this critical period and an intrauterine contraceptive device ( IUD), the most commonly used reversible method of contraception worldwide could be an excellent choice during this period.
There were few evidences available about the safety and feasibility on practicing this type of contraception when we did start three years ago and no previous evidences in Iraq about practicing this method at the immediate postpartum period.
Read the detailed description
Setting and design:
It is a single arm prospective clinical trial. That had been conducted at Al Elweyia Maternity Teaching Hospital and Al Hayat Private Hospital in Baghdad during the period from Sept., 1st, 2015 to Jan.,1st, 2019. Women delivering in those hospitals fulfilling inclusion criteria were included in the study after obtaining informed consent. The study protocol was approved by the ethical committee.
Data collection:
180 women were enrolled in the study, only 150 of them completed the study as thirty women we couldn't reach them through their contact numbers.
Intervention:
They had immediate post-partum insertion of Copper IUD (Cu-T 380A) after delivery of placenta immediately at cesarean delivery. To overcome the considerable expulsion rate in the previous studies, we stabilize the IUD in place at the uterine fundus by an absorbable suture; vicryl 0 that was introduced through the fundus ( from out to in), held the needle with sponge holder that was introduce up the fundus and taken out the vicryl through the lower uterine incision, cutting the needle, warped the vicryl around the the T arm of the IUD and withdrawn back to be placed inside the uterine cavity near the fundus. Before closing the uterine incision, the threads were placed in the lower uterine segment, then the uterine incision was closed routinely.
Follow up:
Women were assessed before discharge from the hospital looking for any excessive bleeding and were provided with a mobile number to call, in case she has any problem with the device that had been inserted.
Women were reassessed at six weeks postpartum, where speculum examination was done and if IUD threads was seen, they were trimmed at 2 cm from external os, otherwise if the threads of IUD were not seen a pelvic ultrasonography was done to confirm the presence of IUD in situ.
Women then were reassessed at yearly intervals for 3 years, looking for the occurrence of excessive bleeding during subsequent menstruation, for abdominal pain and abnormal vaginal discharge, missed threads, expulsion rate, continuation rate and how far they do recommend this method of contraception for other women.
Statistical analysis:
The data analyzed using Statistical Package for Social Sciences (SPSS) version 25. The data presented as mean, standard deviation and ranges. Categorical data presented by frequencies and percentages. Chi square test was used to assess the association between complication of IUD and certain information. Significance level was set at P < 0.05.
- Conditions
- Contraception Behavior
- Being tested
- Copper Intra uterine contarceptive device ( Cu-T 380A)
- Keywords
- Long acting reversible contraception, Post placental insertion of intrauterine device, Cesearean section, Safety, Feasibility
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper Intra uterine contarceptive device ( Cu-T 380A)Device
Insertion of the Cu-T 380A during cesarean delivery immediately after placental removal.
| Study group | Role | What they receive |
|---|---|---|
| Post placental intra uterine device insertion | Experimental | There was immediate post-partum insertion of CuT 380 A intrauterine device after delivery of placenta during cesarean delivery. To overcome the considerable expulsion rate in the previous studies, we stabilize the IUD in place at the fundus be an absorbable suture; vicryl 0 that was introduced through the fundus, held the needle with sponge holder that was introduce up the fundus and taken out the vicryl through the lower uterine inscion, cutting the needle, hold the vicryl around the the T arm of the IUD and withdrawn back to be placed inside the fundus. Before closing the uterine incision, the threads were placed in the lower uterine segment, then the uterine incision was then closed routinely. Receives: Device: Copper Intra uterine contarceptive device ( Cu-T 380A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the women accept to be engaged in this services.
Assessing the acceptability of the women for the service of IUD insertion during the immediate postpartum period after cesarean delivery.
Measured: First 6 months of the study
Cost of IUD insertion during the immediate postpartum period.
Assessing the cost for the insertion of the device in the immediate postpartum period.
Measured: Up to 3 years.
Time spent for IUD insertion during the immediate postpartum period
Assessing the extra time spent for the insertion of the device in the immediate postpartum period.
Measured: Up to 3 years
Secondary outcomes (2)
Percentage of Immediate complications
Number of the women having immediate complications including excessive blood loss before discharge from the hospital.
Measured: First 48 hours post cesarean section.
Percentage of other complications
Number of the women having heavy menstrual blood loss, abdominal pain, abnormal vaginal discharge, missed threads, perforation and expulsion rate.
Measured: Six months and yearly up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start1 Sep 2015
- Primary completion1 Jan 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraception BehaviorStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group: Clinical trials with a single arm
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taghreed Alhaidari
- Sponsor type
- University, hospital or other
- Collaborators
- Elweyia Maternity Teaching Hospital
- Responsible party
- Sponsor-investigator, Taghreed Alhaidari, Al-Kindy College of Medicine
- Investigators
- Taghreed K Alhaidari, CABOG, Study chair, Al Kindy College of Medicine, University of BaghdadTaghreed K Alhaidari, CABOG, Principal investigator, Al Kindy College of Medicine, University of BaghdadAsmaa T Majeed, FICOG, Principal investigator, Al Kindy College of Medicine, University of BaghdadSahar J Al-Jassani, CABOG, Principal investigator, Al Kindy College of Medicine, University of BaghdadHayder A Fawzi, FICMS, Principal investigator, Department of Pharmacy, Al-Esraa University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136613
- Sponsor's protocol ID
- 9 Al-KindyCM
- Status last verified
- Jan 2020
- First submitted
- 16 Oct 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Post Placental Insertion of Intrauterine Device at Cesarean Delivery, is Acceptable, Feasible and Safe in Iraqi Women.
- ClinicalTrials.gov ID
- NCT04136613
- Acronym / sponsor ID
- 9 Al-KindyCM
- Conditions
- Contraception Behavior
- Keywords
- Long acting reversible contraception, Post placental insertion of intrauterine device, Cesearean section, Safety, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Taghreed AlhaidariUniversity, hospital or other
- Collaborators
- Elweyia Maternity Teaching Hospital
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 23 Oct 2019 (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.
Iraq is a country that ranks 33rd around world population growth rate. Meanwhile it is one of the counties in the middle east with the highest fertility rate, In addition to the considerable number of unintended pregnancy mainly in postpartum period.
The less use of family planning methods, the higher the fertility rate and the less interpregnancy interval which will carry an obvious more risk to the mother and the fetus especially if the cesarean delivery rate shown an increase trend as the case in Iraq. For that reason, contraception needs to be practiced in this critical period and an intrauterine contraceptive device ( IUD), the most commonly used reversible method of contraception worldwide could be an excellent choice during this period.
There were few evidences available about the safety and feasibility on practicing this type of contraception when we did start three years ago and no previous evidences in Iraq about practicing this method at the immediate postpartum period.
Detailed description
Setting and design:
It is a single arm prospective clinical trial. That had been conducted at Al Elweyia Maternity Teaching Hospital and Al Hayat Private Hospital in Baghdad during the period from Sept., 1st, 2015 to Jan.,1st, 2019. Women delivering in those hospitals fulfilling inclusion criteria were included in the study after obtaining informed consent. The study protocol was approved by the ethical committee.
Data collection:
180 women were enrolled in the study, only 150 of them completed the study as thirty women we couldn't reach them through their contact numbers.
Intervention:
They had immediate post-partum insertion of Copper IUD (Cu-T 380A) after delivery of placenta immediately at cesarean delivery. To overcome the considerable expulsion rate in the previous studies, we stabilize the IUD in place at the uterine fundus by an absorbable suture; vicryl 0 that was introduced through the fundus ( from out to in), held the needle with sponge holder that was introduce up the fundus and taken out the vicryl through the lower uterine incision, cutting the needle, warped the vicryl around the the T arm of the IUD and withdrawn back to be placed inside the uterine cavity near the fundus. Before closing the uterine incision, the threads were placed in the lower uterine segment, then the uterine incision was closed routinely.
Follow up:
Women were assessed before discharge from the hospital looking for any excessive bleeding and were provided with a mobile number to call, in case she has any problem with the device that had been inserted.
Women were reassessed at six weeks postpartum, where speculum examination was done and if IUD threads was seen, they were trimmed at 2 cm from external os, otherwise if the threads of IUD were not seen a pelvic ultrasonography was done to confirm the presence of IUD in situ.
Women then were reassessed at yearly intervals for 3 years, looking for the occurrence of excessive bleeding during subsequent menstruation, for abdominal pain and abnormal vaginal discharge, missed threads, expulsion rate, continuation rate and how far they do recommend this method of contraception for other women.
Statistical analysis:
The data analyzed using Statistical Package for Social Sciences (SPSS) version 25. The data presented as mean, standard deviation and ranges. Categorical data presented by frequencies and percentages. Chi square test was used to assess the association between complication of IUD and certain information. Significance level was set at P < 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group: Clinical trials with a single arm
| Arm | Type | Receives |
|---|---|---|
| Post placental intra uterine device insertion | Experimental | Device: Copper Intra uterine contarceptive device ( Cu-T 380A)There was immediate post-partum insertion of CuT 380 A intrauterine device after delivery of placenta during cesarean delivery. To overcome the considerable expulsion rate in the previous studies, we stabilize the IUD in place at the fundus be an absorbable suture; vicryl 0 that was introduced through the fundus, held the needle with sponge holder that was introduce up the fundus and taken out the vicryl through the lower uterine inscion, cutting the needle, hold the vicryl around the the T arm of the IUD and withdrawn back to be placed inside the fundus. Before closing the uterine incision, the threads were placed in the lower uterine segment, then the uterine incision was then closed routinely. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who delivered by caesarean section whether elective or emergency, counseled for IUD insertion in pre- natal period or at the time of labour and who has the will and her husband to be engaged in the study.
Key exclusion criteria (6 listed)
- Women with positive test for STIs (e.g. gonorrhea or chlamydia) in this pregnancy.
- Uterine anomaly that was known to distort the uterine cavity; whether uterine fibroid or congenital uterine anomalies.
- Developed postpartum hemorrhage.
- Diagnosed chorioamnionitis, intrapartum fever, or ruptured membranes for greater than 24 hours prior to delivery.
- Placenta previa or accrete.
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 Intra uterine contarceptive device ( Cu-T 380A)Insertion of the Cu-T 380A during cesarean delivery immediately after placental removal. | Device | Post placental intra uterine device insertion |
Primary outcome
Number of the women accept to be engaged in this services.
Time frame: First 6 months of the study
Assessing the acceptability of the women for the service of IUD insertion during the immediate postpartum period after cesarean delivery.
Cost of IUD insertion during the immediate postpartum period.
Time frame: Up to 3 years.
Assessing the cost for the insertion of the device in the immediate postpartum period.
Time spent for IUD insertion during the immediate postpartum period
Time frame: Up to 3 years
Assessing the extra time spent for the insertion of the device in the immediate postpartum period.
2 secondary outcomes
Percentage of Immediate complications
Time frame: First 48 hours post cesarean section.
Percentage of other complications
Time frame: Six months and yearly up to 3 years
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 18 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Contraception Behavior
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Recruiting
"Vasectomy: Right for Me?" Decision Support Tool
Vasectomy, Contraception
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.
Taghreed K Alhaidari, CABOG study chair
Al Kindy College of Medicine, University of Baghdad
Taghreed K Alhaidari, CABOG principal investigator
Al Kindy College of Medicine, University of Baghdad
Asmaa T Majeed, FICOG principal investigator
Al Kindy College of Medicine, University of Baghdad
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 Intra uterine contarceptive device ( Cu-T 380A) in people with Contraception Behavior, run by Taghreed Alhaidari at 1 site in Iraq.
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 6 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 18 Jan 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 Iraq. 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?
Number of the women accept to be engaged in this services. (time frame: First 6 months of the study). The study lists 3 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 18 Jan 2020.