Contraception Behavior Clinical Trial
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.
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incision, cutting the needle, warped the vicryl around the the T arm of the IUD and withdrawn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.
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