Utility of Immediate Post Placental Insertion of Intrauterine Device During Cesarean Delivery

NCT04136613 | Completed

• 1 other identifier: 9 Al-KindyCM
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Contraception Behavior

Keywords

Long acting reversible contraception; Post placental insertion of intrauterine device; Cesearean section; Safety; Feasibility

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to 3 years

Secondary Outcomes (2)

• Percentage of Immediate complications

  First 48 hours post cesarean section.

• Percentage of other complications

  Six months and yearly up to 3 years

Study Arms (1)

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.

Device: Copper Intra uterine contarceptive device ( Cu-T 380A)

Interventions

Copper Intra uterine contarceptive device ( Cu-T 380A) DEVICE

Insertion of the Cu-T 380A during cesarean delivery immediately after placental removal.

Post placental intra uterine device insertion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Taghreed Alhaidari: lead
• Elweyia Maternity Teaching Hospital: collaborator

Study Sites (1)

Al Kindy College of Medicine/ University of Baghdad

Baghdad, 10096, Iraq

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Officials

• Taghreed K Alhaidari, CABOG

  Al Kindy College of Medicine, University of Baghdad

  STUDY CHAIR

• Taghreed K Alhaidari, CABOG

  Al Kindy College of Medicine, University of Baghdad

  PRINCIPAL INVESTIGATOR

• Asmaa T Majeed, FICOG

  Al Kindy College of Medicine, University of Baghdad

  PRINCIPAL INVESTIGATOR

• Sahar J Al-Jassani, CABOG

  Al Kindy College of Medicine, University of Baghdad

  PRINCIPAL INVESTIGATOR

• Hayder A Fawzi, FICMS

  Department of Pharmacy, Al-Esraa University College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor/ Consultant Obstatricain & Gynecologist / Head of Scientific Affairs Unit

Model Details: Single Group: Clinical trials with a single arm

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 23, 2019
• Study Start: September 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)