Vaginal application of acetic acid 3% gel to hasten induction of abortion in women with mid-trimestric missed abortion
| ISRCTN | ISRCTN75746444 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75746444 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/10/2010
- Registration date
- 10/01/2011
- Last edited
- 07/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Karim Abd-El-Maeboud
Scientific
Scientific
2 Mobarak St.
Off Asmaa fahmy
Ard El-Golf
Cairo
11341
Egypt
| kabdelmaeboud@yahoo.com |
Study information
| Study design | Randomised controlled single centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Assessment of efficacy and saftey of vaginal acidity enhancement with 3% acetic acid on response to vaginal misoprostol induction of abortion in missed mid-trimesteric abortion |
| Study hypothesis | Enhacement of vaginal acidity induces cervical softening leading to more successful termination of pregnancy (TOP) with misoprostol along with shorter induction-abortion interval. |
| Ethics approval(s) | The Ethics and Research Committee of Obstetrics and Gynaecology Department, Faculty of Medicine, Ain Shams University approved in September 2010 |
| Condition | Termination of pregnancy (TOP) |
| Intervention | This trial took place at Ain Shams University Maternity Hospital. The participants will be randomly allocated to the following two groups: 1. Group I: Subjects (n = 24) who will be treated with acidifying vaginal gel (acetic acid 3%) applied every 12 hours, starting 2 days ahead of the planned procedure 2. Group II: Subjects (n = 24) who will be treated with neutral (placebo) vaginal gel (the base of the gel without active agent) applied every 12 hours, starting 2 days ahead of the planned procedure During the pre-selection visit, exclusion and inclusion criteria will be applied. When the patient's consent is obtained, the investigator will receive the medication package with a label carrying the corresponding number. Baseline investigations - ABO and rhesus blood group, complete blood count (CBC), random blood sugar, serum glutamate oxalate transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), serum creatinine, and coagulation profile will be done. The investigators will supervise application of the medication (dose by dose) from the package carrying the number matching with the patient's entry number. The biometrician will keep the sealed envelopes with the numbers of order till the end of the study. The medication will be strictly allocated in the numbers order, according to the randomization plan. The randomization schedule will be constructed so that the number in each group would be balanced for every 10 women recruited. Subjects withdrawn from the study before the onset of uterine pains will not be substituted. The next patient included in the study will receive the next number. Before digital vaginal examination, a speculum examination will be performed and vaginal pH value will be measured by using indicator paper (pH-indicator strips pH 0-14 Universal indicator paper, Merck KGbA, Darmstadt, Germany). The indicator will be held with an artery forceps against the vaginal wall in the midvagina- until it becomes wet. Then, another indicator paper will be held with an artery forceps against the vaginal wall - high up in the vagina - until it becomes wet. Colour change of the strip will be immediately compared with the colorimetric scale and the measurement of vaginal pH at the two positions, mid and high vagina, will be recorded. Digital vaginal examination will be then performed assessing three criteria only. These are dilatation, length, position (posterior, midway, anterior or central), and consistency (firm or soft). After pretreatment with the vaginal gel for two days, induction of abortion will performed, starting at 8 am. Peri-abortion prophylaxis will entail metronidazole 1 g rectally at the time of abortion plus doxycycline 100 mg orally twice daily for 7 days, commencing on the day of abortion. All women will receive misoprostol 800 mg vaginally, then misoprostol 400 mg vaginal, 4-hourly, to a maximum of five doses in the first 24 hours. Before inserting the tablet in the posterior fornix, it will be wetted with acetic acid (7%) to assure its complete dissolution. If a woman does not have adequate uterine contractions within 8 hours following the last dose, the same regimen will be repeated over the following 24 hours and if no response was achieved, this will be considered a failure of therapy, and alternative interventions (treatment with high-dose oxytocin, administration of extra-amniotic prostaglandin F2á, mechanical cervical dilatation with a 16-French Foley balloon catheter or performing a hysterotomy) are to be carried out on the basis of judgment of the clinicians. Vital signs of the patients including temperature, pulse rate, blood pressure and the frequency of uterine contractions will be monitored every 3 h, with a recording of the time of the onset of regular uterine contractions, and the time of the expulsion of conceptus. Pethidine hydrochloride 50 mg will be given for pain relief if women requested. After abortion, the products of conception (fetus and placenta) will be examined to see whether the abortion was complete, Evacuation of the uterus will be performed under general anaesthesia only if the placenta is found to be incomplete. The amount of blood loss during abortion will be assessed clinically. After abortion, oxytocin 50 U/ 1000 mL normal saline will be administered intravenously at the rate of 100 mL/h. The side-effects of misoprsotol therapy, including nausea, vomiting, diarrhea, fever and marked abdominal pain, will be recorded. Anti-D immunoglobulin G (250 iu before 20 weeks of gestation and 500 iu thereafter) will be given, by injection into the deltoid muscle, to all non-sensitized RhD negative women within 72 hours following termination. The abortus will be handled to the pathologist for further study. Following termination of pregnancy, women will be given a written account of the symptoms they may experience and a list of those that would make an urgent medical consultation necessary. They will be given a 24-hour telephone helpline number to use if they feel worried about pain, bleeding or high temperature. Urgent clinical assessment and emergency gynaecology admission will be available when necessary. Also, each woman will be offered a follow-up appointment within 2 weeks of the termination. On discharge, each woman will be given a letter that includes sufficient information about the procedure, with referral for further genetic counseling if necessary. Future contraception will be discussed before discharge following termination. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Acetic acid (3% gel), misoprostol |
| Primary outcome measure | Efficacy will be assessed on the basis of improved cervical softening as evidenced by success of induction and its duration. The main outcome measures are 1. Successful abortion rate (defined as expulsion of fetus within 12, 24 and 48 h after administration of misoprsotol) 2. Induction-to-abortion interval (defined as the duration between the application of the first dose of misoprsotol and the time of the expulsion of the fetus) 3. The total dose of misoprsotol used |
| Secondary outcome measures | 1. Drug tolerability as judged by the investigator will be collected and analyzed 2. Side-effects of misoprostol, including vomiting, diarrhoea, fever (defined as a single temperature reading exceeding 38°C), marked abdominal pain along with the need for analgesic and its total dose 3. Blood loss will be estimated visually by the attending obstetrician and excessive bleeding will be defined as an estimated blood loss of 500 ml or more 4. The rate of incomplete abortion (the need for surgical evacuation of the uterus) |
| Overall study start date | 10/11/2010 |
| Overall study end date | 10/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 48 |
| Participant inclusion criteria | 1. Aged 18 - 40 years 2. Missed abortion 3. Singleton pregnancy 4. Gestational age ranging between 14 and 26 weeks of pregnancy (by calculation, examination and/or ultrasound) 5. Uterus and cervix apparently normal on clinical examination 6. Cervix not dilated with absence of effacement 7. Absence of uterine activity 8. Written and signed informed consent by the patient to participate in the study |
| Participant exclusion criteria | 1. A contraindication to medical termination of pregnancy, e.g. placenta praevia 2. Evidences suggesting onset of spontaneous abortion (uterine contractions with or without cervical changes) 3. Presence of vaginal bleeding 4. Presence of intrauterine contraceptive device (IUCD) in situ 5. Presence of ruptured membranes and/or suspicion of septic abortion as evidenced by maternal temperature of 38°C or more, uterine tenderness or foul-smelling vaginal discharge 6. Previous trial to induce abortion or the use of pre-induction agent during the current pregnancy 7. Any contraindication to receiving prostaglandins, including known hypersensitivity to misoprostol or other prostaglandins (PGs), history of asthma, glaucoma, cardiac or cardiovascular disease 8. Parity six or more 9. Multifetal pregnancy 10. Polyhydramnios 11. Uterine anomaly, previous two or more caesarean sections, previous uterine surgery, e.g., myomectomy or trauma, e.g., uterine perforation 12. History of any cervical surgery or manipulation: cervical cerclage during current pregnancy history thereof during a previous pregnancy, previous cauterization of cervical erosion, previous cervical dilatation or operation with resultant apparent cervical tears or lacerations 13. Associated collagen or autoimmune medical disorder 14. Metabolic acidosis as a result of a medical disorder 15. History of adverse effects to vaginally administered medications 16. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol which include all vaginal forms of medications 17. Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study |
| Recruitment start date | 10/11/2010 |
| Recruitment end date | 10/03/2011 |
Locations
Countries of recruitment
- Egypt
Study participating centre
2 Mobarak St.
Cairo
11341
Egypt
11341
Egypt
Sponsor information
Ain Shams University Maternity Hospital (Egypt)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof Karim H I Abd-El-Maeboud
Abbassia
Cairo
11566
Egypt
| obsgyn.asu@gmail.com | |
| Website | http://med.shams.edu.eg/index.php |
"ROR" |
https://ror.org/00p59qs14 |
Funders
Funder type
Hospital/treatment centre
Ain Shams University Maternity Hospital (Egypt)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2012 | Yes | No |
