Utility of Immediate Post Placental Insertion of Intrauterine Device During Cesarean Delivery
Condition: Contraception Behavior
Study type: Interventional

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.
    

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.
    

Intervention name(s): Copper Intra uterine contarceptive device ( Cu-T 380A)
Intervention type(s): Device
Intervention description(s): Insertion of the Cu-T 380A during cesarean delivery immediately after placental removal.
Intervention MeSH terms: Copper
Intervention model: Single Group Assignment
Intervention model description: Single Group: Clinical trials with a single arm
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Long acting reversible contraception; Post placental insertion of intrauterine device; Cesearean section; Safety; Feasibility