Designing the interview

A) The participant, after counselling and signing the informed consent to be part of the study, was allowed to make a choice of contraceptive device she preferred and then taken to the insertion room for clinical examination, specimen collection and IUD insertion.

B) Clinical examination and Specimen Collection- At the insertion room, the participant was placed in lithotomy position. A general pelvic examination was carried out. The vulva was inspected and with sterile gloves and under an aseptic technique. The labia were parted to inspect the vagina orifice. The vagina was cleaned with sterile water and a sterile bi-valve speculum was passed into the vagina to expose the cervix and the posterior fornix, which was carefully examined for discharges, discoloration or any pathology. A sterile swab was used to take samples from the endo-cervix and posterior vaginal fornix. These two swabs were immediately sent to the laboratory for microbiological studies. Participants who have symptoms or clinical evidence of cervico-vaginal infection or PID were not recruited into the study.

C) They were given post-insertion instruction and told when to return to the clinic for next review and follow-up. They were also told of the importance of not using certain drugs (like antibiotics and steroids) in the course of the study and to present to the investigator’s clinic if they had any gynaecological complaints. In case of any problem, the women were

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immediately seen by the investigators and evaluated and treated accordingly.

The questionnaire (Appendix II) contained questions on client biodata, sexual history, previous history of STIs or PID, and smoking status, number of sexual partners in the past year and past obstetrical history. They were counselled and educated on the adverse events and the need for them to present if they had any.

Clinical Methods

Insertion of the Cu T380A IUD or LNG-IUS

Copper T380A contraceptive device comes in a sealed package and has the horizontal and vertical arm with strings attached to the vertical arm. There is also an insertion tube with Flange depth-gauge and a white rod.

Procedure: The client was positioned in a lithotomy position in the insertion room.

The operator, who is the investigator or skilled research assistant wore a sterile glove and used an aseptic technique. The vulva was inspected then a Cusco’s speculum (after lubricating with sterile water) was passed into the vagina to expose the cervix. A careful examination of the cervix and vagina was done for any lesion, discharge and presence or absence of vaginal discharge was noted in the data entry form.

The swabs were then taken from the posterior fornix of the vagina and the endo-cervical canal without cleaning any discharge or secretion. These were labelled appropriately. A bimanual examination was performed. The cervix and the vagina was cleaned with chlorhexidine. The clean speculum repassed and the tenaculum used to grasp the anterior lip of the cervix to hold the uterus steady during insertion and reduce the angle between the cervical and endometrial canals. The uterine sound was passed through the cervix into the uterus to determine the depth and position of the uterus.

Loading the Cu T380A

To prepare the device for insertion, it was ensured that the vertical stem of the T was fully inside the inserter tube. With the package on a clean, hard flat surface with the

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clear plastic side up, the end was opened approximately half way to the flange depth-gauge.

While holding the package with open end up, and “flaps” away from each other, the white rod was put into the inserter tube to almost touch the bottom of the T. Care was taken not to touch tip of rod or brush it against another surface. Then the package was placed on the flat surface once again, with the clear plastic side up.

Through the clear plastic cover, the thumb and index finger were placed over the ends of the horizontal arms of the T and bent the arms towards the stem of the T as indicated on the package I.D. card. The other hand was used to push inserter tube against arms of T. The loading was completed by bending of the arms by bringing thumb and index finger together while using the other hand to manoeuvre the inserter tube to pick up the arms of the T. The folded arms were inserted into the tube only as far as necessary to ensure retention of the arms. The movable gauge was adjusted so that it indicated the depth of the uterus and the direction in which the arms of the T opened.

The cover of the package was peeled and the loaded inserter lifted, keeping it horizontal; so that the T of rod did not fall out and also ensured the inserter assembly did not touch any unsterile surface that would contaminate it.

Inserting the Loaded Cu T380A

The loaded inserter assembly was inserted through the cervical canal and advanced upwards until the T lies in contact with the fundus, and the gauge met the cervix, ensuring that the gauge was in the horizontal plane. While holding the rod stationary, the insertion tube was withdrawn not more than ½ inch. Once the arms have been released, the inserter tube was carefully pushed upwards; towards the top of the uterus until a slight resistance was felt. The inserter tube was held stationary while moving the white rod and then gently withdrew first the white rod and then the inserter tube from the cervical canal. The strings were cut so that they protruded only 3-4cm into the vagina. The woman was assisted from the table slowly and instructed on how and when to check the string. Questions were taken from her and

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she was instructed on the visits as well as what to do or whom and how to contact for help if needed.

LNG-IUS has two horizontal arms, hormone cylinder, removal threads, insertion tube with a flange depth-gauge and a plunger. It releases 20 micrograms of levonorgestrel per 24hours.

Loading and insertion of the LNG-IUS

The plastic covering was opened far enough to reveal the insertion tube. While keeping the removal, threads stretched, the plunger was placed in the insertion tube.

Then the threads were grasped and the device pulled slowly and steadily into the insertion tube until the knobs at the ends of the horizontal arms of the system cover the distal opening of the tube. While steadying the flange with one hand, the tube was moved until the distance between the tip of the loaded inserter and the edge of the flange nearest to the operator corresponded to the sounds measure. The flange was placed in the same plane as the arms when horizontal, then the loaded system was removed from the plastic cover and gently into the cervical canal until the flange touches the cervix. The plunger was held still and the horizontal arms of the system released by pulling the insertion tube only until the edge of the insertion tube reached the grooved part. While holding the tube and plunger together, the system was gently pushed until the flange again touched the cervix. Then the system was released completely from the insertion tube by holding the plunger still and then pulling the tube until it touched the ring part of the plunger. The plunger was removed by keeping the tube stationary and then the tube was carefully removed making sure that the removal threads run freely through the tube and do not draw the system from its fundal position in the uterine cavity. The removal thread is cut short so that 2 cm remain visible outside the cervix.

Post-Insertion Instruction

The participants were taken off the examination/insertion couch after the IUDs have been inserted and were instructed to maintain good hygiene, should not use tampon for sanitary protection during menstruation and check the string of the IUDs daily

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when bathing. They were told not to use any antibiotics and not to douche with antiseptic soaps or agents without consultation with the clinic.